Safety Of Antidepressant Medications Research Articles

Yoga-based lifestyle intervention for antenatal depression (YOGA-D): study protocol for a pilot randomized controlled trial

Background Depression during pregnancy is associated with pre-term labor, low birthweight, post-partum depression and adverse child outcomes. There are concerns about the safety of anti-depressant medications during pregnancy. Many pregnant women with antenatal depression are neither aware about their depression nor do they have access to non-pharmacological interventions for depression. Evidence suggests that pre-natal yoga can improve antenatal depression. Yoga is native to the Indian culture and women can practice yoga as a ‘self-care’ intervention with minimal training. There is no study till date on the efficacy of yoga on antenatal depression in pregnant women in a low resource (rural) setting in India. This pilot randomized controlled trial aims to study the feasibility, acceptability, and preliminary efficacy of a YOGA -based lifestyle intervention for Antenatal D epression (YOGA-D) in Maharashtra, India. Methods We will undertake a single-blind individual randomized parallel group-controlled pilot trial with 1:1 allocation ratio. Adult women with 12–26 weeks of pregnancy, without any obstetric or medical complications will be randomly allocated to either the active intervention group (Yoga-Sanskar (YS)) or the Enhanced Usual Care (EUC) group. Trained yoga instructors will teach a pre-defined yoga sequence to the participants in the YS arm. In the EUC arm, participants will receive a single session of health education. We will assess trial feasibility using the recruitment, retention, and study completion rates. The primary outcome of depression will be measured using the translated Marathi version of the Patient Health Questionnaire-9. Assessments will be at the baseline, three-months post-randomization, and post-delivery. Discussion This study will help us to understand the barriers in implementation of a yoga-based intervention for antenatal depression in a low-resource/rural setting in Maharashtra, India. Based on the learnings of this pilot trial, we plan to undertake an explanatory randomized controlled trial in the next few months. Registration CTRI (CTRI/2024/05/067176; 10/05/2024).

Comparative efficacy and tolerability of first-generation and newer-generation antidepressant medications for depressive disorders in children and adolescents: study protocol for a systematic review and network meta-analysis

IntroductionDepressive disorders are among the most common psychiatric disorders in children and adolescents, and have adverse effects on their psychosocial functioning. Questions concerning the efficacy and safety of antidepressant medications...

Treatment of affective disorders in cardiac disease

Patients with cardiovascular disease (CVD) commonly have syndromal major depression, and depression has been associated with an increased risk of morbidity and mortality. Prevalence of depression is between 17% and 47% in CVD patients. Pharmacologic and psychotherapeutic interventions have long been studied, and in general are safe and somewhat efficacious in decreasing depressive symptoms in patients with CVD. The impact on cardiac outcomes remains unclear. The evidence from randomized controlled clinical trials indicates that antidepressants, especially selective serotonin uptake inhibitors, are overwhelmingly safe, and likely to be effective in the treatment of depression in patients with CVD. This review describes the prevalence of depression in patients with CVD, the physiological links between depression and CVD, the treatment options for affective disorders, and the clinical trials that demonstrate efficacy and safety of antidepressant medications and psychotherapy in this patient population. Great progress has been made in understanding potential mediators between major depressive disorder and CVD--both health behaviors and shared biological risks such as inflammation.

TREATMENT OF DEPRESSION IN CARDIOVASCULAR DISEASE

Depression in patients with Cardiovascular Disease (CVD) is extremely common, with a prevalence of 17-47%, and is associated with increased risk of morbidity and mortality. Treatment of depression has been hypothesized to reduce cardiac mortality. Pharmacologic and psychotherapeutic interventions have been studied and appear to be safe and in some studies effective in reducing depressive symptoms in patients with cardiac disease. The impact on cardiac outcomes remains unclear. This review briefly focuses on the prevalence of depression in patients with CVD, the physiological links between depression and CVD, and largely is concerned with the clinical trials that seek to demonstrate efficacy and safety of antidepressant medications and psychotherapy in this patient population. PubMed and PsycINFO databases were searched through July 2012. Publications were included if they were in English, a review article, or a clinical trial in the CVD population with comorbid depression. The search was completed with key words of antidepressants, CVD, coronary artery syndrome, SSRIs, depression, treatment of depression, post-MI (where MI is myocardial infarction), major depression, and cardiac disease. Trials were included if the patients were above the age of 18, both male and female genders, and had cardiac comorbidity. No trials were excluded. A total of 61 articles and/or book chapters were included. The majority were from North America and Europe. There were 7 clinical trials of tricyclic antidepressants (TCAs), one of TCAs and bupropion, and 10 trials of selective serotonin reuptake inhibitors (SSRIs). We also evaluated five trials involving psychotherapeutic techniques and/or collaborative care. There is considerable evidence from randomized controlled clinical trials that antidepressants, especially SSRIs, are safe in the treatment of major depression in patients with CVD. Although efficacy has been demonstrated in some, but not all, trials for both antidepressants and certain psychotherapies, large, well-powered trials are urgently needed. There are virtually no data available on predictors of antidepressant response in depressed patients with CVD. Whether successful treatment of depression is associated with a reduction in cardiac morbidity and mortality remains unknown.

Rationale and design of the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

Major Depressive Disorder (MDD) affects one in five patients with Chronic Kidney Disease (CKD) and is an independent risk factor for hospitalization and death before and after dialysis initiation. However, it remains an under-recognized and under-treated problem, in part due to the lack of well-controlled studies that support or refute the efficacy and safety of antidepressant medications in CKD patients. Major trials of antidepressant treatment excluded patients with stages 3–5 CKD, precisely those at higher risk for both depression and increased mortality. The Chronic Kidney Disease Antidepressant Sertraline Trial (CAST) is a randomized, double-blinded, placebo-controlled trial of sertraline, a selective serotonin reuptake inhibitor (SSRI). It will enroll 200 adults with stages 3–5 CKD and MDD excluding kidney transplant and chronic dialysis patients. Sertraline will be administered at an initial dose of 50mg once daily or matching placebo followed by a dose escalation strategy consisting of 50mg increments at 2week intervals (as tolerated) to a maximum dose of 200mg. The primary outcome is improvement in depression symptom severity measured by the Quick Inventory of Depressive Symptomatology scale. Secondary outcomes include safety endpoints and improvement in quality of life. Changes in cognitive function, adherence to medications, nutritional status, inflammation, and platelet function will be explored as potential mechanisms by which depression may mediate poor outcomes. We discuss the rationale and design of the CAST study, the largest placebo-controlled trial aimed to establish safety and efficacy of a SSRI in the acute phase treatment of CKD patients with MDD.

Antidepressants for agitation and psychosis in dementia

Agitation and psychosis are common among older adults with dementia and are challenging to manage. At the present time, little is known about the efficacy and safety of antidepressant medications when used to treat these symptoms. To assess the safety and efficacy of antidepressants in treating psychosis and agitation in older adults with Alzheimer's disease, vascular, or mixed dementia. We searched the Cochrane Dementia and Cognitive Improvement Group's Specialized Register which included Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 3), MEDLINE (January 1950 to October 2009), EMBASE (1980 - October 2009), CINAHL (all dates - October 2009) and PsycINFO (1806 to October 2009). Randomized, controlled trials of antidepressants (selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, trazodone, and other antidepressants), compared to either placebo or comparator medications (typical or atypical antipsychotics, anticonvulsants, benzodiazepines, cholinesterase inhibitors, memantine or other medications) for treatment of agitation or psychosis in older adults with dementia. Two authors independently assessed trial quality and extracted trial data. We collected information on efficacy as measured by dementia neuropsychiatric symptom rating scales and adverse effects. Study authors were contacted for additional information. Nine trials including a total of 692 individuals were included in the review. Five studies compared SSRIs to placebo and two studies were combined in a meta-analysis for the outcome of change in Cohen-Mansfield Agitation Inventory (CMAI) scores. There was a significant difference between antidepressants and placebo on measures of agitation as reported on the change in CMAI total score (mean difference (MD), -0.89, 95% CI, -1.22 to -0.57) although the results were heavily weighted by one large study. There were no significant differences in change in behavioral symptoms of dementia for SSRIs compared to placebo in the one study that reported on changes in the Neuropsychiatric Inventory and Behavioral Pathology in Dementia scales. One study comparing citalopram to placebo found a significant difference in NPS as measured on the Neurobehavioral Rating Scale (NBRS) after controlling for baseline severity NBRS score although the unadjusted mean difference was not statistically significant (MD - 7.70, 95% CI: -16.57 to 1.17). There was no difference in the rates of trial withdrawals due to adverse events for SSRIs compared to placebo for four studies reporting this outcome (relative risk (RR), 1.07, 95% CI: 0.55 to 2.11) or in the number of trial withdrawals due to any cause in the three studies reporting this outcome (RR, 0.91, 95% CI, 0.65 to 1.26). One study compared the SSRI citalopram to the atypical antipsychotic risperidone and found no difference in NBRS scores, trial withdrawals due to any cause or trial withdrawals due to adverse events although the rates of adverse events as measured on the UKU side effect scale total score were lower for citalopram (MD -2.82, 95% CI: -4.94 to -0.70). Three studies compared SSRIs to typical antipsychotics. In meta-analysis of two studies there was no statistically significant differences in changes in CMAI total scores (MD, 4.66, 95% CI: -3.58 to 12.90). There was also no difference in trial withdrawals due to any cause or due to adverse events for SSRIs compared to typical antipsychotics. One study of trazodone compared to placebo did not find any significant difference in change in CMAI total scores (MD, 5.18, 95% CI, -2.86 to 13.22) or trial withdrawals due to any cause (RR, 1.06, 95% CI, 0.54 to 2.09). Two studies comparing trazodone to haloperidol also failed to detect any difference in change in CMAI total scores (MD, 3.28, 95% CI, -3.28 to 9.85) or trial withdrawals due to any cause (RR, 0.79, 95% CI, 0.43 to 1.46). Currently there are relatively few studies of antidepressants for the treatment of agitation and psychosis in dementia. The SSRIs sertraline and citalopram were associated with a reduction in symptoms of agitation when compared to placebo in two studies. Both SSRIs and trazodone appear to be tolerated reasonably well when compared to placebo, typical antipsychotics and atypical antipsychotics. Future studies involving more subjects are required to determine if SSRIs, trazodone, or other antidepressants are safe and effective treatments for agitation and psychosis in dementia.

Safety of Antidepressant Medications During Pregnancy

Safety of Antidepressant Medications During Pregnancy