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An open-label, rater-blinded, flexible-dose, 8-week trial of escitalopram in patients with major depressive disorder with atypical features.

ABSTRACT: OBJECTIVES:Although selective serotonin reuptake inhibitors (SSRIs) have become the standard of care for the treatment of major depressive disorder (MDD), limited data exist to support their use in MDD with atypical features. The current study investigates the efficacy of the SSRI escitalopram in an 8-week, open-label, flexible-dose, rater-blinded trial. METHOD:Seventeen DSM-IV MDD subjects aged from 18 through 65 years completed screening procedures, provided informed consent, and went through a minimum 2-week washout from preexisting antide-pressants except fluoxetine (a minimum 4-week wash-out). They subsequently received escitalopram (10-20 mg/day) for 8 weeks. The primary efficacy measure was a change in score from baseline to end of treatment on the Structured Interview Guide for the Hamilton Rating Scale for Depression-Seasonal Affective Disorder version (SIGH-SAD), which includes a set of items for atypical symptoms. Secondary efficacy measures were defined as changes from baseline to end of treatment in scores on the SIGH-SAD atypical symptoms subscale (consisting of 8 items specific to atypical features), Beck Depression Inventory-II, Beck Anxiety Inventory, Sheehan Disability Scale, and Epworth Sleepiness Questionnaire. The study was conducted from October 2005 to November 2006. RESULTS:The mean age was 43.9 years, and 70.6% of subjects were women. The dropout rate was 11.8% (N = 2/17). The mean dose of escitalopram was 18.3 mg/day. The total SIGH-SAD score (mean ± SD) reduced by 53.8% from baseline (33.3 ± 8.2) to end of treatment (15.4 ± 9.4) (t = 4.24, p < .001). The atypical symptoms subscale score reduced by 44.5% from baseline (11.0 ± 4.3) to end of treatment (6.1 ± 2.8) (t = 5.26, p = .001). Ten subjects (62.5%) were classified as responders at end of treatment as defined by ? 50% reduction in SIGH-SAD total score. Overall, escitalopram was well tolerated. CONCLUSIONS:Our preliminary study indicates that escitalopram may be beneficial in the treatment of MDD with atypical features. Adequately powered, randomized, double-blind, placebo-controlled trials are necessary to determine the efficacy of escitalopram in this disorder. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00610506.

SUBMITTER: Pae CU

PROVIDER: S-EPMC2446493 | biostudies-literature | 2008

REPOSITORIES: biostudies-literature

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An open-label, rater-blinded, flexible-dose, 8-week trial of escitalopram in patients with major depressive disorder with atypical features.

Pae Chi-Un CU Masand Prakash S PS Peindl Kathleen K Mannelli Paolo P Han Changsu C Marks David M DM Patkar Ashwin A AA

Primary care companion to the Journal of clinical psychiatry 20080101 3

<h4>Objectives</h4>Although selective serotonin reuptake inhibitors (SSRIs) have become the standard of care for the treatment of major depressive disorder (MDD), limited data exist to support their use in MDD with atypical features. The current study investigates the efficacy of the SSRI escitalopram in an 8-week, open-label, flexible-dose, rater-blinded trial.<h4>Method</h4>Seventeen DSM-IV MDD subjects aged from 18 through 65 years completed screening procedures, provided informed consent, an ...[more]

PMID: 18615172

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Project description:BackgroundIn clinical practice, physicians often need to change the antipsychotic medications they give to patients because of an inadequate response or the presence of unacceptable or unsafe side effects. However, there is a lack of consensus in the field as to the optimal switching strategy for antipsychotics, especially with regards to the speed at which the dose of the previous antipsychotic should be reduced. This paper assesses the short-term results of strategies for the discontinuation of olanzapine when initiating risperidone.MethodsIn a 6-week, randomized, open-label, rater-blinded study, patients with schizophrenia or schizoaffective disorder, on a stable drug dose for more than 30 days at entry, who were intolerant of or exhibiting a suboptimal symptom response to more than 30 days of olanzapine treatment, were randomly assigned to the following switch strategies (common risperidone initiation scheme; varying olanzapine discontinuation): (i) abrupt strategy, where olanzapine was discontinued at risperidone initiation; (ii) gradual 1 strategy, where olanzapine was given at 50% entry dose for 1 week after risperidone initiation and then discontinued; or (iii) gradual 2 strategy, where olanzapine was given at 100% entry dose for 1 week, then at 50% in the second week, and then discontinued.ResultsThe study enrolled 123 patients on stable doses of olanzapine. Their mean age was 40.3 years and mean (+/- standard deviation (SD)) baseline Positive and Negative Syndrome Scale (PANSS) total score of 75.6 +/- 11.5. All-cause treatment discontinuation was lowest (12%) in the group with the slowest olanzapine dose reduction (gradual 2) and occurred at half the discontinuation rate in the other two groups (25% in abrupt and 28% in gradual 1). The relative risk of early discontinuation was 0.77 (confidence interval 0.61-0.99) for the slowest dose reduction compared with the other two strategies. After the medication was changed, improvements at endpoint were seen in PANSS total score (-7.3; p < 0.0001) and in PANSS positive (-3.0; p < 0.0001), negative (-0.9; p = 0.171) and anxiety/depression (-1.4; p = 0.0005) subscale scores. Severity of movement disorders and weight changes were minimal.ConclusionWhen switching patients from olanzapine to risperidone, a gradual reduction in the dose of olanzapine over 2 weeks was associated with higher rates of retention compared with abrupt or less gradual discontinuation. Switching via any strategy was associated with significant improvements in positive and anxiety symptoms and was generally well tolerated.Trial registrationClinicalTrials.gov NCT00378183.

Project description:Vortioxetine is approved for the treatment of adults with major depressive disorder. This open-label extension (OLE) study evaluated the safety and tolerability of vortioxetine in the long-term treatment of major depressive disorder patients, as well as evaluated its effectiveness using measures of depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, OLE study in patients who completed one of three randomized, double-blind, placebo-controlled, 8-week vortioxetine trials. All patients were switched to 10 mg/day vortioxetine for week 1, then adjusted between 15 and 20 mg for the remainder of the study, but not downtitrated below 15 mg. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), vital signs, laboratory values, physical examination, and the Columbia-Suicide Severity Rating Scale. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Hamilton Anxiety Scale, the Clinical Global Impression Scale-Severity of Illness, and the Sheehan Disability Scale. Of the 1075 patients enrolled, 1073 received at least one dose of vortioxetine and 538 (50.0%) completed the study. A total of 537 patients withdrew early, with 115 (10.7% of the original study population) withdrawing because of TEAEs. Long-term treatment with vortioxetine was well tolerated; the most common TEAEs (≥10%) were nausea and headache. Laboratory values, vital signs, and physical examinations revealed no trends of clinical concern. The mean Montgomery-Åsberg Depression Rating Scale total score was 19.9 at the start of the extension study and 9.0 after 52 weeks of treatment (observed cases). Similar improvements were observed with the Hamilton Anxiety Scale (Δ-4.2), the Clinical Global Impression Scale-Severity of Illness (Δ-1.2), and the Sheehan Disability Scale (Δ-4.7) total scores after 52 weeks of treatment (observed case). In this 52-week, flexible-dose OLE study, 15 and 20 mg vortioxetine were safe and well tolerated. After entry into this study, patients continued to show improvement in depression and anxiety symptoms, as well as overall functioning, throughout the treatment period.

Dataset Information

An open-label, rater-blinded, flexible-dose, 8-week trial of escitalopram in patients with major depressive disorder with atypical features.

Publications

An open-label, rater-blinded, flexible-dose, 8-week trial of escitalopram in patients with major depressive disorder with atypical features.

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