Insomnia Subscale Research Articles

Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program

BackgroundBrexanolone is currently the only treatment specifically approved for postpartum depression (PPD) in the United States, based on the results from one Phase 2 and two Phase 3 double-blind, randomized, controlled trials in the HUMMINGBIRD program. MethodsAdults with PPD randomized to a 60-h infusion of brexanolone 90 μg/kg/h (BRX90) or placebo from the 3 trials were included in these post hoc analyses. Data on change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, HAMD-17 Anxiety/Somatization and Insomnia subscales, and Clinical Global Impression of Improvement (CGI-I) scale were pooled. Response rates for HAMD-17 (≥50 % reduction from baseline) and CGI-I (score of 1 or 2) scales and time to response were analyzed. ResultsPatients receiving BRX90 (n = 102) versus placebo (n = 107) achieved a more rapid HAMD-17 response (median, 24 vs 36 h; p = 0.0265), with an Hour-60 cumulative response rate of 81.4 % versus 67.3 %; results were similar for time to CGI-I response (median, 24 vs 36 h; p = 0.0058), with an Hour-60 cumulative response rate of 81.4 % versus 61.7 %. CFB in HAMD-17 Anxiety/Somatization and Insomnia subscales also favored BRX90 versus placebo, starting at Hour 24 through Day 30 (all p < 0.05), and response rates for both subscales were higher with BRX90. LimitationsThe study was not powered to assess exploratory outcomes. ConclusionsBrexanolone was associated with rapid improvement in depressive symptoms and symptoms of anxiety and insomnia compared with placebo in women with PPD. These data continue to support the use of brexanolone to treat adults with PPD.

Insomnia Complaints and Perceived Immune Fitness in Young Adults with and without Self-Reported Impaired Wound Healing.

Background and Objectives: Adequate sleep and an effective immune system are both essential to maintain a good health status. The current study aimed to determine the nature of insomnia complaints and perceived immune fitness among Dutch young adults with and without self-reported impaired wound healing. Materials and Methods: A total of (n = 2033) Dutch students (83.8% women) completed an online survey. Perceived immune fitness was assessed with a single-item scale and insomnia complaints with the SLEEP-50 insomnia subscale. The sample comprised a control group without self-reported impaired wound healing (n = 1622), a wound infection (WI) group (n = 69), a slow healing wounds (SHW) group (n = 250), and a COMBI group that experienced both WI and SHW (n = 92). Results: Comparisons with the control group revealed that individuals of the SHW and COMBI groups reported significantly poorer perceived immune functioning, increased insomnia complaints and daytime fatigue, and poorer sleep quality. Conclusions: Individuals with self-reported impaired wound healing have a poorer perceived immune functioning, increased insomnia complaints, daytime fatigue, and poorer sleep quality.

Base transceiver station antenna exposure and workers’ health

Objectives. With the rapid development of technologies related to the communications industry, human exposure to electromagnetic fields has increased during recent decades. The study aimed at investigating the effect of exposure to waves emitted from the base transceiver stations (BTS) on workers' health. Methods. 240 workers participated in the study. In order to determine the general health conditions in two groups, along with electromagnetic waves exposure measurement, the general health questionnaire (GHQ) was completed and the data on blood parameters were assessed. Results. The mean age and job experience in the case and control groups were 34.1 ± 4.8 and 10.1 ± 6 years and 31.6 ± 5.5 and 8.8 ± 7 years, respectively. According to the GHQ results, only anxiety and insomnia subscales showed a significant difference between the two groups. The white blood cell and red blood cell counts in the case and control groups were 6715.6 ± 1591 and 7594 ± 2416, 5.3 × 106 ± 4.6 × 105 and 5.05 × 106 ± 5.39 × 105 per ml, respectively. Analysis of the results showed that the difference between the two groups was significant. Conclusion. The results revealed that blood parameters in the BTS operators showed more changes. Thus, it can be concluded that these health impacts result from occupational exposure to BTS waves.

Association between urine 6-sulfatoxy-melatonin level and intravesical Bacillus Calmette-Guerin treatment-induced sleep quality deterioration in patients with non-muscle invasive bladder cancer.

The level of 6-sulfatoxy-melatonin (SaMT), a metabolite of melatonin, in first-void morning urine reflects blood melatonin levels from the previous night. We investigated the association between urine SaMT and sleep quality deterioration in patients with non-muscle invasive bladder cancer (NMIBC) treated with intravesical Bacillus Calmette-Guerin induction therapy (iBCG). We enrolled 51 patients who received iBCG once weekly for 6 or 8weeks. Patient-reported outcomes were assessed with questionnaires including the International Prostate Symptom Score (IPSS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQC30). Questionnaires were completed before (baseline), during, at completion, and 1 and 3months after iBCG. Melatonin and SaMT levels at baseline were measured in serum and first-void morningurine samples, respectively. Based on changes in the QLQC30 insomnia subscale, 28 (55%) patients experienced sleep quality deterioration (deterioration group). Urine SaMT values in the deterioration group were lower than those in the non-deterioration group (P = 0.0015; 7.5 vs 15.4ng/mg creatinine, respectively). Nocturia scores in the non-deterioration group decreased over time, while those of the deterioration group remained high after completion of iBCG. A binary logistic regression analysis revealed that low urine SaMT levels (≤ 9.6 ng/mg creatinine), high IPSS nocturia scores at baseline, and high IPSS storage subscores at baseline were associated with BCG-induced sleep quality deterioration. This study confirmed the association among urine SaMT levels, nocturia, and sleep disturbance in patients with NMIBC who receive iBCG. We should be aware of treatment-induced impairments to aid in appropriate decision-making.

0535 Evaluation of Insomnia Symptoms in a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial of Sage-217 in Postpartum Depression

Abstract Introduction Postpartum depression (PPD) is a specifier of major depressive disorder (MDD) with peripartum onset. SAGE-217, an investigational, oral neuroactive steroid GABAA receptor positive allosteric modulator, demonstrated improvements in depressive and anxiety symptoms versus placebo in a Phase 3 trial in PPD (NCT02978326; ROBIN) and a pivotal trial in MDD (NCT03000530). In PPD and MDD, insomnia symptoms are key diagnostic features, comorbid sleep disorders are frequent, and insomnia is a common residual symptom. Here we conducted post-hoc analyses to assess insomnia symptoms in the ROBIN trial. Methods Women (n=151) ages 18-45, ≤6 months postpartum, with PPD (major depressive episode beginning in 3rd trimester or ≤4 weeks postpartum) and a Hamilton Rating Scale for Depression (HAM-D) total score ≥26, were randomized 1:1 to receive outpatient SAGE-217 30mg or placebo for two weeks, with 4 weeks follow-up. Change from baseline (CFB) in HAM-D score at Day 15 was the primary endpoint. Secondary endpoints included CFB in HAM-D at other time points and the Montgomery-Åsberg Depression Rating Scale (MADRS). Post-hoc analyses assessed HAM-D insomnia subscale (HAM-D-Ins) and MADRS individual insomnia item (MADRS-Ins) scores. HAM-D and MADRS measures were evaluated using a mixed-effects model for repeated measures. Safety and tolerability were assessed by adverse event (AE) reporting. Results SAGE-217 demonstrated statistically significant Day 15 CFB versus placebo in HAM-D (primary endpoint: -17.8 vs. -13.6, p=0.0028), MADRS (-22.1 vs. -17.6, p=0.0180), and associated insomnia sub-scales/items (difference SAGE-217 vs. placebo; HAM-D-Ins: -1.003, p=0.0038; MADRS-Ins: -0.773, p=0.0116). Significant CFB in insomnia sub-scales/items favoring SAGE-217 were observed by Day 3 (HAM-D-Ins: -0.841, p=0.0142; MADRS-Ins: -0.710, p=0.017) and at Day 45 (HAM-D-Ins: -0.730, p=0.0207; MADRS-Ins: -0.636, p=0.0221). Most common (≥5%) AEs were somnolence, headache, dizziness, upper respiratory tract infection, diarrhea, and sedation. Conclusion SAGE-217 demonstrated improvements in depression symptoms, including insomnia symptoms, and was generally well tolerated. Support This study was sponsored by Sage Therapeutics, Inc.

Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study

Study objectivesSleep disruption is a significant symptom of major depressive disorder (MDD). To our knowledge, no prior work has examined the impact of repetitive transcranial magnetic stimulation (rTMS) on sleep disturbances in adolescents with MDD. MethodsSeventeen adolescents with treatment-resistant depression received 30 daily sessions of 10-Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC). Clinical symptoms were assessed at baseline; after 10, 20, and 30 treatments; and at a 6-month follow-up visit. Insomnia was measured with a 3-item subscale of the Quick Inventory of Depressive Symptomatology–Adolescent (17 Item)–Self Report (QIDS-A17-SR). Hypersomnia was measured with a single QIDS-A17-SR item. Depression severity was rated with the Children's Depression Rating Scale, Revised (CDRS-R). The effect of rTMS on sleep was examined via linear mixed model analyses, with fixed effects of time (as a proxy of treatment), depression severity, age, and hypnotic medication use. ResultsNo significant main effect of time was observed on the insomnia subscale (F4,43.442 = 1.078, p = 0 .379). However, there was a significant main effect of time on the QIDS-A17-SR hypersomnia score (F4,46.124 = 2.733, p = 0 .040), with significant improvement from baseline to treatment 10 (padj = 0.019) and from baseline to 6-month follow-up (padj = 0.044). In exploratory sensitivity analyses, response/nonresponse to rTMS for overall depressive symptoms had no significant effect on sleep outcomes. ConclusionsrTMS may have intrinsic effects on hypersomnia apart from its antidepressant effects in depressed adolescents. Future work should utilize sham controls and objective, quantitative measurements of sleep architecture to assess effects of rTMS in depressed adolescents. Clinical trial registryClinicaltrials.gov identifiers are NCT00587639, NCT01502033, NCT01804270.

Exploratory analyses of effect modifiers in the antidepressant treatment of major depression: Individual-participant data meta-analysis of 2803 participants in seven placebo-controlled randomized trials

BackgroundIt is clinically important to know who are likely to respond more or less to antidepressants. However, meaningful effect modifiers (variables associated with differential response depending on the treatment) are yet to be identified. MethodsWe conducted individual participant data (IPD) meta-analysis and meta-regression to explore effect modifiers in placebo-controlled antidepressant trials conducted so far in Japan. ResultsWe obtained access to IPD from seven placebo-controlled trials comparing bupropion, duloxetine, escitalopram, mirtazapine, paroxetine or venlafaxine with placebo in the acute phase treatment of major depression (total n = 2803). The higher the guilt subscale score of the baseline Hamilton Rating Scale for Depression (HRSD), the greater the difference in reduction in depression severity between the antidepressants and placebo at week 6, while the older the current age or the age at onset, the smaller the difference. At week 8, the guilt subscale score of HRSD and presence of suicidal ideation at baseline predicted greater, and the anhedonia subscale and insomnia subscale scores of HRSD and early response at week 2 predicted smaller, difference in reduction. LimitationsDifferent studies measured different sets of baseline variables and we were able to analyze only a limited set of candidate variables for effect modification. ConclusionAge, age at onset, several HRSD subscales including guilt, anhedonia and insomnia, presence of suicidal ideation at baseline and early response are potential effect modifiers for response to antidepressants in the acute phase antidepressant treatment of major depression. Future trials need to measure these and additional variables in concerted efforts to enable matching of treatments with individual characteristics in depression.

The relationship of mental health with resilience among psychiatric nurses

Background &amp; Aim: Psychiatric wards are stressful environments. Resilience can help psychiatric nurses cope with their occupational stress. The aim of the study was to examine the relationship of mental health with resilience among psychiatric nurses. Materials &amp; Methods: This cross-sectional descriptive-correlational study was conducted in 2017 on a sample of sixty nurses purposively recruited from all wards of Qods psychiatric hospital, Sanandaj, Iran. Study data were collected using a demographic questionnaire, the 28-item General Health Questionnaire, and the 25-item Connor-Davidson Resilience Scale. The data were analyzed via the SPSS software v. 16.0 through conducting the independent-sample t test, the one-way analysis of variance, and the multiple linear regression analysis. The level of significance was set at less than 0.05. Results: In total, sixty psychiatric nurses (34 males and 26 females) with a mean age of 33.23±5.45 participated in this study. The mean scores of their mental health and resilience were 57.35±11.12 and 63.9±14.05, respectively. Resilience had significant relationships with age (0.025), marital status (P = 0.013), and work shift (P = 0.005). Moreover, among the subscales of mental health, only the mean score of the anxiety and insomnia subscale had significant relationship with resilience, so that each one point increase in the mean score of this subscale was associated with a 1.029-point increase in the mean score of resilience (P = 0.036). Conclusion: Psychiatric nurses’ resilience can be promoted through managing their stress and promoting their mental health.

The association between insomnia and perceived health status

Introduction: Impaired sleep can have a significant impact on perceived health status. The aim of the current study was to examine the relationship between perceived health status and sleep quality, total sleep time, and insomnia. Materials and methods: A survey was conducted among Dutch university students. General health and perceived immune status were scored on a scale ranging from 0 (very poor) to 10 (excellent). Sleep parameters were collected with the insomnia subscale of the SLEEP-50 questionnaire. Total sleep time (TST) was recorded, and sleep quality was scored on a scale ranging from 0 (very poor) to 10 (excellent). Non-parametric correlations (Spearman)were used to examine the association between perceived heath and immune status and the sleep parameters. Results: N = 509 subjects completed the survey (N = 143 men, and N = 366 women). They were on average 20.8 (2.6) years old and reported a TST of 7.7 (0.9) hours. Mean (SD) scores were 14.6 (4.3) for insomnia, 7.3 (1.2) for sleep quality, 7.7 (1.0) for general health, and 7.8 (1.3) for perceived immune status. Perceived general health correlated significantly with scores for insomnia (r = -0.228, p = 0.0001) and sleep quality (r = 0.235, p = 0.0001), but not with TST (r = 0.058, p = 0.196). Similarly, perceived immune status correlated significantly with scores for insomnia (r = -0.193, p = 0.0001) and sleep quality (r = 0.234, p = 0.0001), but not with TST (r = 0.051, p = 0.254). A significant correlation was found between perceived health status and immune functioning (r = 0.704, p = 0.0001). Insomnia scores were highly correlated to sleep quality (r =-0.697, p = 0.0001) and to a lesser extent with TST (r = -0.218, p = 0.0001). Overall, the observed associations were stronger in men when compared with women. Conclusion: Whereas insomnia and sleep quality were significantly related to perceived general health and immune status, this relationship was not found for total sleep time.

Manifestations of Insomnia in Sleep Apnea: Implications for Screening and Treatment

The aims of this study were to examine the presence, type, and severity of insomnia complaints in obstructive sleep apnea (OSA) patients and to assess the utility of the Sleep Symptom Checklist (SSC) for case identification in primary care. Participants were 88 OSA patients, 57 cognitive-behavioral therapy for insomnia (CBT-I) patients, and 14 healthy controls (Ctrl). Each completed a sleep questionnaire as well as the SSC, which includes insomnia, daytime functioning, psychological, and sleep disorder subscales. Results showed that OSA patients could be grouped according to 3 insomnia patterns: no insomnia (OSA), n = 21; insomnia (OSA-I), n = 30, with a subjective complaint and disrupted sleep; and noncomplaining poor sleepers (OSA-I-NC), n = 37. Comparisons among the OSA, CBT-I, and Ctrl groups demonstrate distinct profiles on the SSC subscales, indicating its potential utility for both case identification and treatment planning.

Effectiveness of a Psychoeducational Intervention Group Program in the Reduction of the Burden Experienced by Caregivers of Patients With Dementia

We conducted a multicenter, prospective, evaluator-blinded, 2-arm parallel randomized trial to compare the effectiveness of a group psychoeducational intervention (PIP) with that of standard care in dementia caregivers. The primary outcome was the burden experience evaluated by the Zarit Burden Interview. Secondary outcomes were psychological distress evaluated with the scaled General Health Questionnaire-28 items, and quality of life evaluated with the Short-Form Health Survey 12. Effectiveness endpoint was at 4 months since inception. Statistical analyses used complete case and intention-to-treat analysis (ITT). The trial recruited 238 caregivers from 22 research sites (115 randomized to PIP, 123 randomized to standard care). No differences were found in the Zarit Burden Interview scores (complete case analysis: mean difference=-1.02, 95% confidence interval=-4.41 to 2.37; ITT analysis: MD=-0.55, 95% confidence interval=-3.64 to 2.55), the Short-Form Health Survey 12 domain scores (all P>0.05), and total General Health Questionnaire-28 items scores and some of its subscales (all P>0.05) except the anxiety and insomnia subscale for the ITT analysis (P=0.03). In summary, PIP in modality of group intervention was not better than standard care to reduce caregiver burden and overall psychological distress or to improve quality-of-life domains. EDUCA-II trial registry: ISRCTN14411440.

Parent-Based Sleep Education for Children with Autism Spectrum Disorders

This study provided sleep education to parents of children with autism spectrum disorder (ASD) to determine whether an individual or group format was more effective in improving sleep and aspects of daytime behavior and family functioning. Eighty children, ages 2-10years, with ASD and sleep onset delay completed the study. Actigraphy and parent questionnaires were collected at baseline and 1month after treatment. Mode of education did not affect outcomes. Sleep latency, insomnia subscales on the Children's Sleep Habits Questionnaire, and other outcomes related to child and family functioning improved with treatment. Parent-based sleep education, delivered in relatively few sessions, was associated with improved sleep onset delay in children with ASD. Group versus individualized education did not affect outcome.

Prevalence and Clinical Correlates of Insomnia in Depressive Disorders: The CRESCEND Study

ObjectiveTo investigate the prevalence, clinical manifestations, and clinical correlates of insomnia in a large cohort of Korean patients with depressive disorders.MethodsWe recruited 944 patients with depressive disorders from the Clinical Research Center for Depression of South Korea (CRESCEND) study. Psychometric scales were used to assess depression (HAMD), anxiety (HAMA), psychotic symptoms (BPRS), global severity (CGI-S), and functioning (SOFAS). Insomnia levels were determined by adding the scores for all items on the HAMD insomnia subscale. The clinical characteristics of the patients with 'low insomnia' (summed score ≤3 on the HAMD subscale) and 'high insomnia' (score ≥4) were compared using statistical analyses. A logistic regression model was constructed to identify factors associated with 'high insomnia' status.ResultsSymptoms of insomnia were present in 93% of patients, while simultaneous early, middle, and late insomnia affected 64.1%. The high insomnia patients were characterized by significantly greater age, higher symptom levels (including core, gastrointestinal somatic and anxiety symptoms, and suicidal ideation), higher global severity and incidence of physical disorders, and greater insight. Explanatory factors of 'high insomnia' status were older age, higher gastrointestinal somatic and anxiety symptom levels, higher global severity, and greater insight.ConclusionIn clinical psychiatry, insomnia has been significantly underdiagnosed and undertreated. It affects most patients with depressive disorders, and is indicative of the global severity of depression. Active efforts to diagnose and treat insomnia in patients with depressive disorders should be strongly encouraged. Further research is needed to improve the diagnosis and treatment of insomnia in depressive patients.

Improvement in delusions and hallucinations in patients with dementia with Lewy bodies upon administration of yokukansan, a traditional Japanese medicine

This multicentre open-label trial examined the efficacy and safety of the traditional Japanese medicine, or Kampo medicine, yokukansan (YKS), for behavioural and psychological symptoms of dementia (BPSD) in patients with dementia with Lewy bodies. Sixty-three dementia with Lewy bodies patients with probable BPSD (M:W, 30:33; mean age, 78.2±5.8 years) were enrolled and treated with YKS for 4 weeks. Significant improvements in Neuropsychiatric Inventory scores (mean decrease, 12.5 points; P<0.001) and Zarit Burden Interview-Japanese edition tests (mean decrease, 3.6 points; P=0.024) were observed. In patients who consented to an assessment after 2 weeks of treatment, a time-dependent significant improvement was observed in the Neuropsychiatric Inventory score (n=23; mean decrease, 14.4; P<0.001), each subscale, including delusions and hallucinations, the Zarit Burden Interview-Japanese edition (n=22; mean decrease, 8.2; P<0.01) and the behavioural pathology in Alzheimer's disease insomnia subscale. The Mini-Mental State Examination and the Disability Assessment for Dementia (DAD) showed no significant change. Adverse events were observed in 11 (18%) patients. Three patients (5%) discontinued YKS due to adverse reactions, namely, spasticity and exacerbation of BPSD, edema, and nausea. Hypokalaemia (<3.5 mEq/L) was present in four patients (6%) at the study endpoint. Worsening of extrapyramidal symptoms was not observed. YKS improved BPSD in dementia with Lewy bodies patients and caregiver burden scores without deterioration in cognitive function. YKS is useful for the treatment of delusions and hallucinations in BPSD.

Family violence influences mental health of school girls in Iran: Results of a preliminary study

IntroductionThe family plays the first and may be the most important role in the development of individuals’ personality, health and function. The current study aimed to evaluate different aspects of violence against a sample of school girls of Iranian population and its effect on their mental health. MethodsA cluster, randomized sample consisting of 399 school girls was selected from all of the high schools in Tabriz city, northwest of Iran. Students were asked to participate in this study anonymously. Signs and symptoms of depression and anxiety were assessed by the General health questionnaire-28 (GHQ-28) measuring their social function and physical situation as well. Another inquiry form involving questions about different kinds of violence and neglect gathered information about their situation during the recent year. ResultsThe mean (SD) age of the students was 14.9 (0.8) and all were under 18. The mean (SD) total score of GHQ-28 was 24.18(13.61). The sub-threshold score in GHQ-28 (under 23) was observed in 44.1% of students which indicates considerable problems in mental health status. The type of reported violence was not significantly associated with an abnormal score of GHQ-28.A higher score of somatic symptoms was related to verbal violence at home by parents and the educational level of mother. High score on social dysfunction was predicted by lower educational level of mother. The depression scale was related to humility, neglect and discrimination at home. The factors were not predicting the score of anxiety or insomnia subscales. DiscussionThe current study observed a noticeable amount of problems in the mental health of teenage girls in a sample of the Iranian population. The educational level of the mother plays an important role in the mental health of school girls.

Consistency and reliability of the Brazilian Portuguese version of the Mini-Sleep Questionnaire in undergraduate students

Questionnaires are indispensable tools in epidemiologic studies and clinical surveys. Many questionnaires focusing on sleep disorders have been described in the literature. This cross-sectional study is aimed to assess the consistency and reliability of the Brazilian Portuguese Version of the Mini-Sleep Questionnaire (MSQ-BR). Self-administered questionnaires were given to a sample of 1,108 undergraduate students. The variables collected were age, gender, socioeconomic level, and MSQ-BR scores. A subgroup of 53 students was randomly chosen to test the test-retest reliability of the instrument. Internal consistency of total MSQ-BR and its subscales (i.e., insomnia and hypersomnia) was evaluated using Cronbach's alpha coefficient. Our results showed good internal consistency of total MSQ-BR score, with a Cronbach's alpha value of 0.770. The insomnia subscale had an adequate internal consistency (Cronbach's alpha, 0.749). On the other hand, the hypersomnia subscale had moderate internal consistency (Cronbach's alpha, 0.624). The test-retest analysis showed good reliability of the instrument using Pearson's correlation coefficient. The MSQ-BR has adequate internal consistency and test-retest reliability. The MSQ-BR insomnia has adequate internal consistency for use as a separate application. However, the MSQ-BR hypersomnia demonstrated only moderate internal consistency for use as a separate application. Our intention was not to introduce modifications to the questionnaire, but to evaluate the reliability of total MSQ-BR and its subscales. Others studies are needed to assess the consistency of MSQ compared to other instruments.

The effect of interpersonal psychotherapy for depression on insomnia symptoms in a cohort of women with sexual abuse histories

Insomnia frequently occurs with trauma exposure and depression, but can ameliorate with improvements in depression. Insomnia was assessed by the insomnia subscale of the Hamilton Rating Scale for Depression in 106 women with childhood sexual abuse (CSA) and major depression receiving interpersonal psychotherapy (IPT) in an uncontrolled pilot (n = 36) and an immediately subsequent randomized controlled trial (n = 70) comparing IPT to treatment as usual. Depression improved in each study and in both treatment conditions; insomnia had smaller, nonsignificant improvements. Overall, 95 women (90%) endorsed insomnia on the Structured Clinical Interview for DSM-IV at baseline and, of those, 90% endorsed insomnia following treatment. Despite improvements in depression, insomnia persists for most women with CSA.

A Sleep Habits Questionnaire for Children With Autism Spectrum Disorders

Sleep difficulties in children with autism spectrum disorders are common, with poor sleep hygiene a contributing factor. We developed the Family Inventory of Sleep Habits to measure sleep hygiene in this population. Its validity and reliability in 2 groups of children aged 4 to 10 years, those with a clinical diagnosis of autism spectrum disorders, and those who are typically developing are described. In both groups, total and modified (reflecting insomnia subscales) scores on the Children's Sleep Habits Questionnaire showed significant negative correlations with the total score. The Peabody Picture Vocabulary Test-III was significantly correlated with total score in the autism spectrum group but not in the typically developing group. Age and socioeconomic status were not correlated with total score in either group. This preliminary work suggests that the Family Inventory of Sleep Habits is a valid and reliable measure of sleep hygiene in autism spectrum disorders.

Clinical impact of duloxetine treatment on sleep in patients with major depressive disorder

The objective of this study was to conduct a meta-analysis of the clinical impact of duloxetine treatment on sleep in adults with major depressive disorder. Data were pooled from 11 placebo-controlled, double-blind studies of duloxetine treatment (8-9 weeks acute therapy, modal dose 60 mg/day). Sleep outcome was assessed by the Hamilton Depression Rating Scale-17 (HAMD(17)) sleep items (onset latency, middle awakening, and early awakening) and their sum (insomnia subscale) and by occurrence of sleep-related treatment-emergent adverse events (TEAEs). Efficacy was measured by HAMD(17) Maier subscale scores. Adult outpatients (mean age: 45.4 years; 65.8% women) were assigned randomly to duloxetine (N=1760) or placebo (N=1159). Duloxetine-treated patients improved more on the HAMD(17) sleep subscale compared with placebo-treated patients (mean=-1.2 vs. -1.1, P< or =0.05). Sleep-related TEAEs that occurred more frequently for patients treated with duloxetine, compared with placebo, were insomnia (8.9 vs. 5.9%, P< or =0.001), middle insomnia (1.4 vs. 0.3%, P=0.001), and hypersomnia (1.0 vs. 0.3%, P< or =0.01). Patients with sleep-related TEAEs demonstrated similar mean improvement in Maier subscale score as patients without sleep-related TEAEs (P=0.223). Compared with placebo, duloxetine treatment was associated with a positive, but negligible, benefit on clinical ratings of insomnia and with more frequent sleep-related TEAEs that did not negatively impact overall efficacy for major depressive disorder.

Which symptoms predict recurrence of depression in women treated with maintenance interpersonal psychotherapy?

Even low levels of residual symptoms are known to increase the risk of relapse and early recurrence of major depression. It is not known if ongoing psychotherapy lessens this risk. We therefore examined the impact of persistent symptoms, including mood, insomnia, and anxiety symptoms, on time to recurrence in women receiving maintenance interpersonal psychotherapy (IPT-M) for recurrent depression. We analyzed data on 131 women aged 20-60 from a 2-year randomized trial of weekly versus twice-monthly versus monthly IPT-M. Participants achieved remission with IPT alone (n=99) or IPT plus sequential antidepressant medication (n=32). Medications were tapered before starting maintenance treatment. Residual symptoms were assessed with the Hamilton Rating Scale for Depression (HRSD; total score and subscales); insomnia was also assessed in 76 women with the Pittsburgh Sleep Quality Index (PSQI). Data analyses used Cox proportional hazards regression models. Neither overall burden of residual symptoms (HRSD total score), nor HRSD mood and anxiety subscale scores predicted recurrence during ongoing IPT-M. In contrast, persistent insomnia measured both by the HRSD-17 insomnia subscale and the PSQI predicted recurrence. Women with persistent insomnia who required sequential pharamacotherapy had the highest recurrence rate (65%) compared to women requiring sequential treatment without insomnia (13%), or women who had recovered with IPT alone but had persistent insomnia (21%) or no insomnia (18%). Persistent insomnia following the recovery from an episode of recurrent major depression is associated with increased risk of recurrence despite maintenance psychotherapy, particularly for those withdrawn from antidepressant medication.