Study Comparing Discontinuation Symptoms Of DVS SR In Subjects With Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01056289
- Lead Sponsor
- Pfizer
- Brief Summary
Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- Primary Diagnosis of Major Depressive Disorder
- Hamilton Psychiatric Rating Scale for Depression-17-Item score of greater than or equal to 14 at baseline
- Current psychoactive substance abuse or dependence, manic episode, or a lifetime diagnosis of bipolar or psychotic disorder
- Potentially violent to others or is at significant risk for suicide
- History or current evidence of gastrointestinal disease or history of surgery known to interfere with absorption or excretion
- Known presence of raised intraocular pressure or history of narrow angle glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Desvenlafaxine Succinate Sustained-Release Formulation 50 mg Desvenlafaxine Succinate Sustained-Release Formulation 50 mg - Desvenlafaxine Succinate Sustained-Release Formulation 25 mg Desvenlafaxine Succinate Sustained-Release Formulation 25 mg - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase 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).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase 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 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.