Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
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|ClinicalTrials.gov Identifier: NCT01056289|
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : February 17, 2012
Last Update Posted : February 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Parallel Group Study To Compare Discontinuation Symptoms In Abrupt Discontinuation Versus A 1-Week Tapering Regimen In Subjects With MDD Treated For 24 Weeks With Open-Label 50 mg DVS SR Formulation|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
|Active Comparator: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg||
Drug: Desvenlafaxine Succinate Sustained-Release Formulation 50 mg
DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
|Active Comparator: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg||
Drug: Desvenlafaxine Succinate Sustained-Release Formulation 25 mg
DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
|Placebo Comparator: Placebo||
DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase.
- Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase [ Time Frame: Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182) ]Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2).
- Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase [ Time Frame: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) ]Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.
- Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms [ Time Frame: Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) ]Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056289
|Study Director:||Pfizer CT.gov Call Center||Pfizer|