Gender Differences In Treatment Response Research Articles

Gender differences in the effect of rtms with the H7-coil on physical and social anhedonia in schizophrenia spectrum disorder; a randomized, sham-controlled trial

IntroductionStudies of differences in the incidence and severity of physical and social anhedonia between women and men diagnosed with schizophrenia spectrum disorder (SSD) are often inconsistent, and gender differences in treatment response have not been well studied. Hormonal factors, such as those related to the menstrual cycle, pregnancy or menopause, as well as social and cultural patterns and roles, may influence treatment response. The incidence of affective or stress-related psychiatric comorbidities may be gender-specific, which could also complicate the treatment of anhedonia and other negative symptoms of SSD. Finally, there is no evidence of sufficient quality on gender differences in the effects of rTMS, but the results are intriguing and point to the need for further research.ObjectivesTo investigate gender differences in the effect of rTMS with the H7-coil on physical and social anhedonia in patients diagnosed with SSD with dominant negative symptoms.MethodsWe conducted a randomized, sham-controlled trial during 2000-2023 in the population of patients diagnosed with SSD with primary negative symptoms defined as PANSS negative symptoms subscale score > 24, and PANSS positive symptoms subscale score < 20. The intervention was HF rTMS H7 coil (Brainsway Ltd. Jerusalem, Israel) once daily for 20 days applied to the prefrontal cortex (mPFC and ACC) at 100% motor threshold with a frequency of 18 Hz, and total of 39600 pulses. The outcomes were Physical and Social Anhedonia Scales (PAS, and SAS). We controlled for the large number of relevant covariates.ResultsWe randomized 49 men and 29 women of similar age. The effect on physical anhedonia was statistically significant in women (b = 9.04; p = 0.016), but not in men (b = 2.87; p = 0.272). The effect on social anhedonia was similar, but the difference was smaller (for men b = 3.71; p = 0.082; for women b = 5.42; p = 0.043). However, the Wald test showed no statistically significant differences between the beta coefficients for women and men.ConclusionsBased on this study, it is not possible to make valid and reliable conclusions about the existence of gender differences in the effects of rTMS treatment of anhedonia with the H7 coil. However, it is possible to claim that the treatment of anhedonia with this protocol is effective in women.Disclosure of InterestNone Declared

Gender-specific outcomes of deep brain stimulation for Parkinson’s disease — results from a single movement disorder center

Introduction and goalThe investigation of gender differences in treatment response is crucial for effective personalized therapies. With only 30%, women are underrepresented in trials for deep brain stimulation (DBS) in Parkinson’s disease (PD). It is therefore important to evaluate gender-specific outcomes of DBS in PD in order to improve therapeutic counseling.MethodsWe analyzed clinical outcome parameters of 203 patients with PD that underwent DBS surgery targeting the subthalamic nucleus (STN) at our movement disorder center. A total of 27.6% of patients were female and 72.4% male. Motor and non-motor scores were compared before and 1 year after DBS surgery (1y FU) using Wilcoxon signed-rank tests and gender specific outcomes were analyzed with chi-square tests.ResultsAt 1y FU, we found significant improvement in UPDRS II, UPDRS III (35.78 ± 36.14% MedOFF vs. StimON-MedOFF), UPDRS IV, depression (BDI-II), and health-related disability as (ADL) that showed no gender-specific differences. No significant change was revealed for UPDRS I, QUIP, and DemTect for the entire cohort. However, when analyzing both groups separately, only women improved in general cognition (plus 1.26 ± 3.03 DemTect points, p = 0.014*), whereas only men ameliorated in depression (minus 1.97 ± 6.92 BDI-II points, p = 0.002**) and impulsivity (minus 2.80 ± 7.27 QUIP points, p = 0.004**). Chi-square tests, however, revealed no significant differences between genders.Conclusion and outlookSTN-DBS is a highly effective treatment for motor and non-motor symptoms of PD for both women and men but our study hints towards gender-specific outcomes in non-motor-domains like cognition, depressive symptoms, and impulsivity. To explore this in more detail, larger cohorts need to be investigated in multicenter trials.

Sex and gender in treatment response to dialectical behaviour therapy: current knowledge, gaps, and future directions

Abstract Borderline personality disorder (BPD) is a mental health condition characterized by emotion dysregulation, interpersonal impairment, and high suicidality. Dialectical behaviour therapy (DBT) is the most widely studied psychotherapeutic treatment for BPD. To date, the vast majority of DBT research has focused on cisgender women, with a notable lack of systematic investigation of sex and/or gender differences in treatment response. In order to encourage effective, equitable treatment of BPD, further investigation into treatment targets in this population is critical. Here, we employed a systematic strategy to delineate gaps in the DBT literature pertaining to sex and gender differences and propose directions for future research. Findings demonstrate a significant discrepancy in measurement of sex and gender, particularly among gender-diverse individuals. Exploring DBT treatment response across the full spectrum of genders will facilitate the provision of more tailored, impactful care to all individuals who suffer from BPD. Key learning aims (1) To date, DBT treatment literature has focused almost exclusively on cisgender women, with only two of 253 DBT studies in current literature accounting for transgender and gender diverse (TGD) individuals. (2) Recognize how gender minority stress may impact the prevalence of BPD among TGD individuals. (3) Learn how future research initiatives can be employed to rectify this gap in the DBT literature.

Gender-based clinical differences in evidence-based treatment for adolescent anorexia nervosa: analysis of aggregated randomized controlled trials.

Boys represent a small proportion of samples in randomized clinical trials (RCT) investigating evidence-based treatment for adolescents with anorexia nervosa (AN). Consequently, knowledge of potential gender differences in clinical characteristics and treatment response in adolescents is considerably limited. Secondary analyses of aggregated data from two RCTs were used to characterize baseline and end-of-treatment clinical features in male and female adolescents with AN (n = 228, 10.53% male). Mixed analyses of variance were used to investigate potential gender differences in treatment response relative to weight outcomes (% median BMI) and eating disorder cognitions (Eating Disorder Examination Global scores; EDE). There were no significant gender differences in prior inpatient care, illness duration, psychiatric comorbidity, or psychotropic medication use at baseline. Nor were there significant gender differences in binge eating, purging, or driven exercise at baseline or end-of-treatment. Girls reported elevated weight and shape concern compared to boys at baseline but overall reduction in EDE Global scores over the course of treatment did not differ according to gender. Boys gained more relative weight during treatment than girls, but this difference was statistically non-significant. Overall findings do not suggest significant differences in treatment outcome relative to weight or ED cognitions, by gender. Current evidence suggests that, with the exception of shape and weight concerns, boys present with cognitive and behavioral symptoms as severe as their female counterparts which underscores the need for increased accuracy in assessment of these disorders in boys and young men. Level 1, secondary data analysis of randomized controlled trials.

Efficacy of a Single, Brief Alcohol Reduction Intervention among Men and Women Living with HIV/AIDS and Using Alcohol in Kampala, Uganda: A Randomized Trial.

We evaluated the efficacy of a brief motivational intervention (MI) counseling in reducing alcohol consumption among persons living with HIV/AIDS in Kampala, Uganda. Persons living with HIV/AIDS with Alcohol Use Disorders Identification Tool (AUDIT) score ≥3 points were randomized to either standardized positive prevention counseling alone or in combination with alcohol brief MI counseling. The mean change in AUDIT-C scores over 6 months was compared by treatment arm. The mean (standard deviation [SD]) AUDIT-C scores were 6.3 (2.3) and 6.8 (2.3) for control and MI arms ( P = .1) at baseline, respectively, and change in mean AUDIT-C score was not statistically different between arms over the 6 months ( P = .8). However, there was a statistically significant decrease in mean AUDIT-C score (-1.10; 95% confidence interval: -2.19 to -0.02, P = .046) among women in the MI arm. There was a nondifferential reduction in alcohol consumption overall, but MI appeared effective among women only. Studies with more than 1 counseling session and evaluation of gender differences in treatment response are needed.

Using Big Data to Assess Prescribing Patterns in Greece: The Case of Chronic Obstructive Pulmonary Disease.

IntroductionChronic Obstructive Pulmonary Disease (COPD) is one of the top leading causes of death and disability, and its management is focused on reducing risk factors, relieving symptoms, and preventing exacerbations. The study aim was to describe COPD prescribing patterns in Greece by using existing health administrative data for outpatients.MethodsThis is a retrospective cross-sectional study based on prescriptions collected by the largest social insurance fund, during the first and last trimester of 2012. Selection criteria were the prescription of specific active substances and a COPD diagnosis. Extracted information included active substance, strength, pharmaceutical form and number of packages prescribed, diagnosis, time of dispensing, as well as insurees’ age, gender, percentage of co-payment and social security unique number. Statistical analysis included descriptive statistics and logistic regression.Results174,357 patients received medicines for COPD during the study period. Patients were almost equally distributed between male and female, and age above 55 years was strongly correlated with COPD. Most patients received a long-acting beta agonist plus inhaled corticosteroid combination (LABA +ICS), followed by long-acting muscarinic agonist (LAMA). 63% patients belonging in the 35–54 age received LABA+ICS. LAMA was prescribed more frequently among males and was strongly correlated with COPD.ConclusionThe study provides big data analysis of Greek COPD prescribing patterns. It highlights the need for appropriate COPD classification in primary care illustrating the role of electronic prescribing in ensuring appropriate prescribing. Moreover, it indicates possible gender differences in treatment response or disease severity, and the impact of statutory co-payments on prescribing.

Gender difference in the response to valsartan/amlodipine single-pill combination in essential hypertension (China Status II): An observational study.

Background:The China STATUS II is a prospective, multicentre, open-label, post-marketing, observational study including Chinese adults (aged ⩾ 18 years) with essential hypertension who were prescribed once-daily valsartan/amlodipine (Val/Aml 80/5 mg) single-pill combination. In order to examine gender differences in treatment response to Val/Aml, we further analysed data from the China STATUS II study.Methods:A total of 11,312 patients (6456 (57%) men and 4856 (43%) women) received the Val/Aml treatment for 8 weeks. After the treatment, we compared the proportion of patients not achieving the target systolic blood pressure (SBP: < 140 mm Hg) or diastolic blood pressure (DBP: < 90 mm Hg) in different age groups (by Fisher exact probability test) and estimated the changes in blood pressure (BP) according to age and gender, using a mixed model.Results:At enrolment, mean SBP was higher in the female versus the male patients (160.0 ± 12.71 versus 159.3 ± 12.31 mm Hg; p = 0.003), whereas the mean DBP was higher in the male versus the female patients (96.4 ± 10.65 versus 94.5 ± 10.72 mm Hg; p < 0.001). The overall proportion of women not achieving the target BP was less than that of men (57.41% versus 59.59%; p < 0.05) at 4 weeks and (22.22% versus 23.78%; p < 0.05) at 8 weeks after the Val/Aml treatment. Among both men and women, the proportion of patients not achieving the target SBP increased with age; however, the proportion not achieving the target DBP decreased with age. The mixed-model analysis showed that the changes in SBP were closely related to gender, indicating that the SBP-lowering effect after Val/Aml treatment might be better in women. In addition, the changes in DBP were closely related to age.Conclusions:Gender might be a factor for consideration in the decision-making process of individualised antihypertensive therapy, in the future.

Long-Term Effects of a Screening Intervention for Depression on Suicide Rates among Japanese Community-Dwelling Older Adults

To explore the long-term impact of a universal screening intervention for depression on suicide rates among older community-dwelling adults, with gender as an effect modifier. Controlled cohort study reporting long-term follow-up of previous research. Two sets of three municipalities in Japan were assigned as intervention and control regions and compared with the surrounding zone and prefecture. Intervention area residents aged 60 years and older (14,291) were invited to participate in a 2-year intervention (2005-2006). Four population-based dynamic cohorts of residents aged 65 years and older (1999-2010) were included as subjects, 6 years before and after the intervention started. At-risk residents within the intervention region (4,918) were invited for a two-step screening program; 2,552 participated in the program linked with care/support services for 2 years. An education program open to the public was held. Changes in suicide from a 6-year baseline to the 2-year intervention and a 4-year follow-up in the intervention region (11,700 adults ≥65 years) were compared with a matched control and two comparison areas using mixed-effects negative binomial regression models. Suicide rates among older adults exposed to screening were compared with those of the control region. Suicide rates in the intervention region decreased by 48%, which was significantly greater than in the three comparison areas. The program's benefits lasted longer for women than men. Screening exposure may be associated with decreased suicide risk over the 4-year follow-up. Universal screening may decrease suicide rates among older adults, with potential gender differences in treatment response.

Treatment of Depression: Men and Women Are Different?

Treatment of Depression: Men and Women Are Different?

Supraphysiologic Doses of Levothyroxine as Adjunctive Therapy in Bipolar Depression

Suboptimal availability of circulating thyroid hormones may contribute to the high rate of treatment failures in bipolar disorder. This study tested the efficacy of adjunctive treatment with supraphysiologic doses of levothyroxine in patients with bipolar depression and the hypothesis that women would display a better outcome compared to men. The aims of this multicenter, 6-week, double-blind, randomized, placebo-controlled fixed-dose (300 μg/d) trial conducted from 2004 to 2009 were to assess efficacy and tolerability of levothyroxine adjunctive to continuing treatment with mood stabilizer and/or antidepressant medication for patients with bipolar I or II disorder, currently depressed (DSM-IV), and to investigate gender differences in treatment response. The primary efficacy variable was mean change in Hamilton Depression Rating Scale (HDRS) score. Of 74 patients enrolled in the study, 62 (35 with bipolar I; mean age = 44.9 years) were randomized. Mean change in HDRS score from randomization to week 6 was larger in the levothyroxine group compared to the placebo group, with a 2.7-point difference (decline of -7.8 [38.3%] vs -5.1 [25.5%]; last-observation-carried-forward analysis). The course of HDRS scores over time from randomization to week 6 was significantly different between groups at week 4 (P = .046) but not at the end of the placebo-controlled phase (P = .198). The secondary analysis of women (n = 32) revealed a significant difference between groups in mean change in HDRS score (-16.6% placebo vs -42.4% levothyroxine, P = .018). A mixed-effects model for repeated-measures analysis showed a significant between-group difference in HDRS score (6.8, P = .012) for women. High thyroid-stimulating hormone levels, indicating suboptimal levels of circulating thyroid hormones, were predictive for positive treatment outcome in women treated with levothyroxine in a linear regression model (F3 = 3.47; P = .05). This trial demonstrated that patients treated with levothyroxine did numerically better than those treated with placebo; however, the study failed to detect a statistically significant difference between the 2 groups in the primary outcome measure due to a high placebo response rate. Previous findings that women show better improvement in depression scores with levothyroxine compared to men were confirmed. ClinicalTrials.gov identifier: NCT01528839.

Gender differences in non-glycemic responses to improved insulin sensitivity by pioglitazone treatment in patients with type 2 diabetes

Excess cortisol and GH induce insulin resistance, a central feature of type 2 diabetes (T2D). To study whether the insulin sensitizer pioglitazone affects basal cortisol levels and the GH-IGF-I axis in patients with T2D. Forty-eight patients with T2D (men/women = 28:20, age 61 ± 1 years, BMI 31 ± 0.6 kg/m(2)) were treated for 26 weeks with pioglitazone 30-45 mg daily in addition to their preexisting therapy. Insulin, proinsulin, HbA(1c), IGF-I, IGFBP-1, and basal cortisol were analyzed before and after treatment. Pioglitazone decreased proinsulin/insulin ratio and HbA(1c) decreased (HbA(1c) from 7.8 ± 0.2 to 6.6 ± 0.2% in men and from 7.6 ± 0.2 to 6.1 ± 0.2% in women, p < 0.001 in both). There was a redistribution of fat but no change in waist circumference. IGF-I and adiponectin increased (p ≤ 0.001) in both genders. IGFBP-1 increased but significantly only for the whole group (p = 0.033). Triglycerides decreased significantly in women only (p = 0.015). Before treatment, women had lower basal cortisol (p = 0.045). Basal cortisol increased in women (from 390 ± 26 to 484 ± 32 nmol/L, p = 0.020) but not in men and did not differ between genders at week 26. ΔIGFBP-1 correlated with Δcortisol (r = 0.458; p = 0.049) and Δadiponectin (r = 0.600; p = 0.005) in women only. In addition to the known effect of improving insulin sensitivity, pioglitazone increased IGF-I regardless of gender and in women also increased basal cortisol. Increased IGF-I may contribute to improved insulin sensitivity after treatment. There seems to be gender differences in treatment responses to pioglitazone on lipid metabolism and basal cortisol, perhaps correcting different mechanisms of insulin resistance between genders.

Gender differences in mortality and CD4 count response among virally suppressed HIV-positive patients.

Treatment outcomes for antiretroviral therapy (ART) patients may vary by gender, but estimates from current evidence may be confounded by disease stage and adherence. We investigated the gender differences in treatment response among HIV-positive patients virally suppressed within 6 months of treatment initiation. We analyzed data from 7,354 patients initiating ART between April 2004 and April 2010 at Themba Lethu Clinic, a large urban public sector treatment facility in South Africa. We estimated the relations among gender, mortality, and mean CD4 response in HIV-infected adults virally suppressed within 6 months of treatment initiation and used inverse probability of treatment weights to correct estimates for loss to follow-up. Male patients had a 20% greater risk of death at both 24 months and 36 months of follow-up compared to females. Older patients and those with a low hemoglobin level or low body mass index (BMI) were at increased risk of mortality throughout follow-up. Men gained fewer CD4 cells after treatment initiation than did women. The mean differences in CD4 count gains made by women and men between baseline and 12, 24, and 36 months were 28.2 cells/mm(3) (95% confidence interval [CI] 22.2-34.3), 60.8 cells/mm(3) (95% CI 71.1-50.5 cells/mm(3)), and 83.0 cells/mm(3) (95% CI 97.1-68.8 cells/mm(3)), respectively. Additionally, patients with a current detectable viral load (>400 copies/mL) and older patients had a lower mean CD4 increase at the same time points. In this initially virally suppressed population, women showed consistently better immune response to treatment than did men. Promoting earlier uptake of HIV treatment among men may improve their immunologic outcomes.

Health-related quality of life in ADHD: a pooled analysis of gender differences in five atomoxetine trials

Attention-deficit/hyperactivity disorder (ADHD) is associated with considerable impairment in health-related quality of life (HR-QoL). Atomoxetine has been found to improve HR-QoL in both children and adolescents. However, there is scarcity of data on gender differences in treatment responses to ADHD medications. This pooled analysis of five atomoxetine trials aimed to evaluate treatment differences with respect to HR-QoL and ADHD symptoms across genders. Data from 5 clinical atomoxetine trials (4 from Europe and 1 from Canada) with similar inclusion and exclusion criteria and similar durations (8- to 12-week follow-up) were included in the pooled analysis. All studies included the Child Health and Illness Profile-Child Edition (CHIP-CE) Parent Report Form. In addition, correlations between HR-QoL and ADHD core symptoms were compared between girls and boys. Data from 136 girls and 658 boys (mean age: 9.6 and 9.7 years, respectively) were pooled. Boys and girls were similarly impaired at baseline with minor differences in some of the subdomains. Treatment effect of atomoxetine was significant in both groups for the Risk Avoidance domain and its subdomains. No gender effect with both clinical and statistical significance was found for treatment outcome. Correlations between ADHD Rating Scale and CHIP-CE scores were similar in both genders and were generally low at baseline and moderate at endpoint and for the change from baseline to endpoint. Atomoxetine was effective in improving some aspects of HR-QoL in both genders without any significant differences across genders. Correlations between core symptoms of ADHD and HR-QoL were low to moderate in both boys and girls.

C.11.03 Ensuring that patients adhere to treatment for depression

Background: The prevalence of major depression for women is about twice that for men. This gender difference in prevalence rates has led to much research addressing gender differences in the presentation and features of major depression, and, to a lesser extent, research addressing gender differences in treatment response and personality. However, studies differ considerably in the population sampled, and findings vary significantly. In the current retrospective examination of data, we investigated all of these variables in one single sample of outpatients with major depression seen in a tertiary care centre. Methods: A sample of 139 men and 246 women with major depression receiving antidepressant treatment (SSRIs, TCAs, SNRIs, MAOIs, or RIMAs) in an outpatient setting were contrasted with regard to symptoms and severity of depression, course of illness, treatment response, and personality. Results: Women were found to experience more vegetative and atypical symptoms, anxiety, and anger than men, and to report higher severity of depression on self-report measures. Regarding personality, women scored higher on conscientiousness, the extraversion facet warmth, the openness facet feelings, and sociotropy. Effect sizes were small to moderate. No differences were found in the course of the illness and treatment response. Limitations: Findings are not generalizable to inpatient or community samples, and some of the gender differences may be accounted for by gender differences in treatment seeking behaviour. Conclusions: While men and women receiving antidepressant treatment show some gender differences in the psychopathology of major depression, these differences do not appear to translate into differences in response to antidepressants. Gender differences in personality appear less profound than in the average population, indicating the potential role of a certain personality type that predisposes individuals to develop clinical depression, independent of gender. Clinical relevance: The current examination underscores the role gender plays in the presentation and treatment of major depression.

Gender Issues in Depression

Gender differences in depression have been documented for many years and thought to be insignificant to treatment selection until recently. This article reviews gender differences in the prevalence, presentation, etiology, and antidepressant treatment of depressive disorders. The high female to male sex ratio in the prevalence of depression, especially during the reproductive years, is one of the most replicated findings in epidemiology. Women more often have a seasonal component, anxious and atypical depression. Explanations for the differences include psychological, neurochemical, anatomic, hormonal, genetic, and personality factors. Gender differences in antidepressant treatment response have not been found consistently. Hormonal status may be an important variable in addition to the effects of the menstrual cycle, pregnancy, perimenopause and menopause. Women have higher rates of depression and can often present differently than do men. Further research can ascertain which combination of factors increase women's risk. The effect of pregnancy and the impact of the menstrual cycle on the course of all depressive disorders need increased attention. Large prospective randomized controlled trials with gender differences in treatment response as the primary endpoint are necessary in order to answer the now controversial question of gender differences in antidepressant treatment response.

Depression in children and adolescents: Does gender make a difference?

The occurrence of depression is higher in females after puberty, suggesting a gender-related difference. This article reviews studies that have examined gender differences in the presentation and treatment of depression in adults and discusses how this information applies to depressed children and adolescents. The adult literature suggests that men and women vary in presentation of depression. In addition, differences exist in the pharmacokinetic properties of various medications, but it is unclear how they affect clinical treatment response. Studies of gender differences in child and adolescent depression are limited. Some studies suggest that differences seen in adults may also apply to children and adolescents. Studies of gender differences in treatment response are not available, however. Further study and evidence-based exploration are required to better understand gender differences in depression in children and adolescents.

Anxiety disorders in women: does gender matter to treatment?

Women have a substantially higher risk of developing lifetime anxiety disorders compared with men. In addition, research evidence has generally observed an increased symptom severity, chronic course, and functional impairment in women with anxiety disorders in comparison to men. However, the reasons for the increased risk in developing an anxiety disorder in women are still unknown and have yet to be adequately investigated. Evidence from various studies has suggested that genetic factors and female reproductive hormones may play important roles in the expression of these gender differences. The significant differences in onset and course of illness observed in men and women diagnosed with anxiety disorders warrants investigations into the need of differential treatment; however, evidence of gender differences in treatment response to different anxiety disorders are varying and remain largely inconclusive. This article reviews the prevalence, epidemiology, and phenomenology of the major anxiety disorders in women, as well as the implications of such differences for treatment.

Sex Differences in Antidepressant Response in Recent Antidepressant Clinical Trials

Some previous reports suggest that women respond differently than men to antidepressant treatment. Much of this literature compares men and women's response to tricyclics to that of newer antidepressants (SSRIs, SNRI), or only examines one particular antidepressant. This study compares men and women's responses to 6 newer antidepressants. A total of 15 randomized, placebo-controlled trials that included 323 depressed patients were examined for sex differences in antidepressant treatment response. Women had a significantly greater response than men to SSRI antidepressants. A similar trend was seen for those assigned to an SNRI antidepressant, although not to the same extent as with SSRI antidepressants. Although these gender differences in treatment response are not large enough to suggest that gender should guide the clinical use of SSRI and SNRI antidepressants, the results do have implications for the design and interpretation of antidepressant clinical trials. These findings also raise the possibility that antidepressants may work somewhat differently in men and women.

Rehabilitation Medicine: Gender differences in treatment response to a chronic pain rehabilitation program

Rehabilitation Medicine: Gender differences in treatment response to a chronic pain rehabilitation program

Gender differences in treatment response to sertraline versus imipramine in patients with nonmelancholic depressive disorders

There is evidence of gender differences in depressive disorders in terms of epidemiology and clinical manifestations. However, few studies have addressed the gender differences in terms of antidepressant treatment response in clinical practice. The aim of this study was to examine gender differences in the acute antidepressant response to sertraline and imipramine in nonmelancholic depressive disorders. A total of 239 patients with nonmelancholic major depression or dysthymia (DSM-III-R) and a score of ≥18 at baseline on the Hamilton Depression Rating Scale (HAM-D) were randomised in a 1:1 ratio treatment with flexible doses of sertraline (50–200 mg/day) or imipramine (75–225 mg/day) for 8 weeks in a multicenter, randomised, open-labeled, parallel group comparative trial. Depressive and anxiety symptoms were assessed using the HAM-D and the Hamilton Anxiety Rating Scale (HAM-A). Using HAM-D criteria, women were significantly more likely to respond to sertraline than to imipramine (72.2% vs. 52.1%, P=.008), whilst men respond similarly to sertraline and to imipramine (56.5% vs. 59.3%, P>.05). Response analysis based on HAM-A shows similar results (women: 68.9% vs. 43.6%, P=.001; men: 56.5% vs. 51.9%, P>.05). Women taking sertraline show statistically significant higher reductions in HAM-D, HAM-A, and in CGI-S than women taking imipramine. The proportion of women who dropped out due to adverse events was much lower in sertraline than in imipramine (10.9% vs. 27.8%, P=.006), with no differences between treatments in men (8.3% vs. 11.5%, P>.05). It was concluded that sertraline is more effective and better tolerated than imipramine in the acute treatment of nonmelancholic depressive disorders in women, whereas men responded similarly to sertraline and to imipramine.