Multi-trial, aggregated, individual participant data mega-analysis of short-term antidepressant versus mood stabilizer monotherapy of bipolar type II major depressive episode.

Background: Few studies have systematically examined the safety and effectiveness of antidepressant versus mood stabilizer monotherapy of bipolar II depression. To date, there are no aggregated or mega-analyses of prospective trials of individual participant-level data (IPD) to inform future treatment guidelines on the relative safety and effectiveness of antidepressant or lithium monotherapy.

Methods: Data from a series of four independent, similarly designed trials of antidepressant or lithium monotherapy (where longitudinal IPD were available) (n = 393) were aggregated into an IPD dataset (i.

Effectiveness and safety of monoamine oxidase inhibitor treatment for bipolar depression versus unipolar depression: An exploratory case cohort study.

Objective: Patients with bipolar disorder spend most of their clinical lifetime in the depressive phase of their illness. However, antidepressants are discouraged in the treatment of bipolar depression due to concerns over manic induction and drug ineffectiveness. Some reports suggest that monoamine oxidase inhibitors (MAOIs) may be safe and effective compared to other antidepressants in treating bipolar depression.

The prescriber's guide to classic MAO inhibitors (phenelzine, tranylcypromine, isocarboxazid) for treatment-resistant depression.

This article is a clinical guide which discusses the "state-of-the-art" usage of the classic monoamine oxidase inhibitor (MAOI) antidepressants (phenelzine, tranylcypromine, and isocarboxazid) in modern psychiatric practice. The guide is for all clinicians, including those who may not be experienced MAOI prescribers. It discusses indications, drug-drug interactions, side-effect management, and the safety of various augmentation strategies.

Putative Antidepressant Effect of Chamomile ( L.) Oral Extract in Subjects with Comorbid Generalized Anxiety Disorder and Depression.

This exploratory analysis examined the putative antidepressant effect of L. (chamomile) extract in subjects with generalized anxiety disorder (GAD) with or without comorbid depression. It was hypothesized that chamomile extract would demonstrate similar anxiolytic activity in both subgroups, but superior antidepressant activity in GAD subjects with comorbid depression.

Prevention of Recurrence After Recovery From a Major Depressive Episode With Antidepressant Medication Alone or in Combination With Cognitive Behavioral Therapy: Phase 2 of a 2-Phase Randomized Clinical Trial.

Importance: Antidepressant medication (ADM) maintenance treatment is associated with the prevention of depressive recurrence in patients with major depressive disorder (MDD), but whether cognitive behavioral therapy (CBT) treatment is associated with recurrence prevention remains unclear.

Objective: To determine the effects of combining CBT with ADM on the prevention of depressive recurrence when ADMs are withdrawn or maintained after recovery in patients with MDD.

Design, Setting, And Participants: A total of 292 adult outpatients with chronic or recurrent MDD who participated in the second phase of a 2-phase trial.

Relative Effectiveness of Monoamine Oxidase Inhibitor and Tricyclic Antidepressant Combination Therapy for Treatment-Resistant Depression.

Purpose/background: We examined the relative safety and effectiveness of adding a monoamine oxidase inhibitor (MAOI) to a failed tricyclic antidepressant (TCA) trial versus adding a TCA to a failed MAOI trial or adding a TCA to a failed TCA trial in treatment-resistant depression.

Methods/procedures: Data were retrospectively harvested from approximately 2500 treatment charts of subjects with treatment-resistant depression who attended a university mood disorders clinic between 1983 and 2015. Hierarchical linear modeling was used to examine the effectiveness of treatment condition on outcome.

Prior Antidepressant Treatment Trials May Predict a Greater Risk of Depressive Relapse During Antidepressant Maintenance Therapy.

Background: We examined the influence of prior antidepressant treatment trials on the likelihood of depressive relapse, and time to depressive relapse, during maintenance therapy of bipolar II disorder in treatment-responsive subjects who had recovered from a major depressive episode.

Methods: Data were derived from a prospective, randomized, double-blind trial of 148 adult subjects with bipolar II major depressive episode who were initially administered open-label fluoxetine monotherapy for 12 weeks. Remitters with a final Hamilton Rating Scale for Depression score of 8 or lower were then randomized to continuation therapy with either fluoxetine (n = 28), lithium (n = 26), or placebo (n = 27) for 50 additional weeks.

Relative effectiveness of tricyclic antidepressant versus monoamine oxidase inhibitor monotherapy for treatment-resistant depression.

Objectives: Antidepressants may be less effective in treatment-resistant depression (TRD). In this exploratory study, we examined the widely held hypothesis that monoamine oxidase inhibitor (MAOI) therapy may be superior to tricyclic antidepressant (TCA) therapy for TRD. We also examined the influence of the number of prior treatment trials on TCA versus MAOI effectiveness in TRD.

Increase in pharmacodynamic tolerance after repeated antidepressant trials in treatment-responsive bipolar I depressed subjects: An exploratory study.

Objectives: This study examined the presence of increased pharmacodynamic tolerance with reduced effectiveness following repeated antidepressant trials over the course of the affective illness in subjects with treatment-responsive bipolar II depression.

Methods: Data were derived from the open-label phase of a prospective, randomized, placebo-controlled trial of long-term fluoxetine versus lithium monotherapy in 148 subjects >=18 years old with treatment-responsive bipolar II depression, who were initially administered open-label fluoxetine monotherapy for 12 weeks. Response was defined as >=50% reduction in baseline Hamilton Rating Scale for Depression (HRSD) score, and remission was defined as a final HRSD score =<8.

Revising , Fifth Edition, criteria for the bipolar disorders: Phase I of the AREDOC project.

Objective: To derive new criteria sets for defining manic and hypomanic episodes (and thus for defining the bipolar I and II disorders), an international Task Force was assembled and termed AREDOC reflecting its role of Assessment, Revision and Evaluation of DSM and other Operational Criteria. This paper reports on the first phase of its deliberations and interim criteria recommendations.

Method: The first stage of the process consisted of reviewing , and recent International Classification of Diseases criteria, identifying their limitations and generating modified criteria sets for further in-depth consideration.

Industry-corrupted psychiatric trials.

The goal of this paper is to expose the research misconduct of pharmaceutical industry sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepresentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine.

Residual anxiety may be associated with depressive relapse during continuation therapy of bipolar II depression.

Background: Anxiety symptoms are common in bipolar disorder. We explored the effect of anxiety on the outcome of acute and continuation pharmacotherapy of bipolar II depression.

Methods: Data were derived from a randomized double-blind 12-week acute (N = 129) and 6-month continuation (N = 55) comparison of venlafaxine versus lithium monotherapy in bipolar II depression in adults.

Effects of venlafaxine versus lithium monotherapy on quality of life in bipolar II major depressive disorder: Findings from a double-blind randomized controlled trial.

Bipolar disorder is associated with decreased quality of life, especially during depressive episodes. There are few studies that have examined whether quality of life improves following pharmacological treatments of bipolar depression. In this exploratory study, we examined the effects of antidepressant versus mood stabilizer monotherapy on quality of life ratings in bipolar II subjects during acute (12 week) treatment.

An exploratory study of salivary cortisol changes during chamomile extract therapy of moderate to severe generalized anxiety disorder.

Objectives: Dysfunctions in stress biology are hypothesized to contribute to anxiety disorders, and to be ameliorated during successful treatment, but limited clinical data exist to support this hypothesis. We evaluated whether increases in morning cortisol and the diurnal cortisol slope, markers of stress biology, are associated with clinical response to chamomile therapy among subjects with generalized anxiety disorder (GAD).

Methods: Among 45 subjects with DSM-IV diagnosed GAD in an open-label clinical trial of chamomile, salivary cortisol was assessed for three days each pre- and post-treatment, at 8am, 12pm, 4pm, and 8pm.

Comparison of treatment outcome using two definitions of rapid cycling in subjects with bipolar II disorder.

Objectives: We examined differences in treatment outcome between Diagnostic and Statistical Manual Fourth Edition (DSM-IV)-defined rapid cycling and average lifetime-defined rapid cycling in subjects with bipolar II disorder. We hypothesized that, compared with the DSM-IV definition, the average lifetime definition of rapid cycling may better identify subjects with a history of more mood lability and a greater likelihood of hypomanic symptom induction during long-term treatment.

Methods: Subjects ≥18 years old with a bipolar II major depressive episode (n=129) were categorized into DSM-IV- and average lifetime-defined rapid cycling and prospectively treated with either venlafaxine or lithium monotherapy for 12 weeks.

Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial.

Background: Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects.

Purpose: To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse.

Short-term open-label chamomile (Matricaria chamomilla L.) therapy of moderate to severe generalized anxiety disorder.

Background: Conventional drug treatments for Generalized Anxiety Disorder (GAD) are often accompanied by substantial side effects, dependence, and/or withdrawal syndrome. A prior controlled study of oral chamomile (Matricaria chamomilla L.) extract showed significant efficacy versus placebo, and suggested that chamomile may have anxiolytic activity for individuals with GAD.

Step-wise loss of antidepressant effectiveness with repeated antidepressant trials in bipolar II depression.

Objective: This study examined the relationship between the number of prior antidepressant treatment trials and step-wise increase in pharmacodynamic tolerance (or progressive loss of effectiveness) in subjects with bipolar II depression.

Methods: Subjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium carbonate monotherapy for 12 weeks. Responders (n=59) received continuation monotherapy for six additional months.

Specific Pharmacological Effects of Paroxetine Comprise Psychological but Not Somatic Symptoms of Depression.

Background: Meta-analyses of placebo-controlled trials of SSRIs suggest that only a small portion of the observable change in depression may be attributed to "true" pharmacological effects. But depression is a multidimensional construct, so treatment effects may differ by symptom cluster. We tested the hypothesis that SSRIs uniquely alter psychological rather than somatic symptoms of depression and anxiety.

The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance.

Objective: Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States.

Methods: Approximately 750 documents from the Celexa and Lexapro Marketing and Sales Practices Litigation: Master Docket 09-MD-2067-(NMG) were deconstructed.

Results: The published article contained efficacy and safety data inconsistent with the protocol criteria.

Rhodiola rosea L. as a putative botanical antidepressant.

Background: Rhodiola rosea (R. rosea) is a botanical adaptogen with putative anti-stress and antidepressant properties. Evidence-based data supporting the effectiveness of R.

Short-term venlafaxine v. lithium monotherapy for bipolar type II major depressive episodes: effectiveness and mood conversion rate.

Background: Controversy exists over antidepressant use in bipolar II depression.

Aims: To compare the safety and effectiveness of antidepressantv.mood stabiliser monotherapy for bipolar type II major depressive episodes.

Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study.

Objective: Compare the safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for preventing depressive relapse in bipolar II disorder.

Methods: Subjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium monotherapy for 12 weeks. Responders with a ≥50% reduction in depression score were continued for an additional 6 months of relapse-prevention monotherapy.

Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial.

Background: We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus sertraline for mild to moderate major depressive disorder.

Hypothesis: We hypothesize that R.