A Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Safety of Vilazodone 40 mg qd and Evaluating Genetic Biomarkers Associated With Treatment Response in Patients With Major Depressive Disorder (MDD)
Overview
- Phase
- Phase 3
- Intervention
- vilazodone
- Conditions
- Major Depressive Disorder
- Sponsor
- Forest Laboratories
- Enrollment
- 481
- Locations
- 8
- Primary Endpoint
- Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.
Detailed Description
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria. This study will enroll approximately 470 patients at approximately 10 clinical sites. Safety and efficacy will be assessed at each visit. A DNA sample will be collected and analyzed for response to vilazodone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 18-70 years of age.
- •A diagnosis of MDD, single episode or recurrent, according to DSM-IV-TR (296.2/296.3) with a current Major Depressive Episode of less than two year's duration with a minimum duration of at least 4 weeks.
- •Meets DSM-IV-TR criteria for Major Depressive Disorder.
- •HAM-D score ≥ 22 on the first 17 items of the 21-item HAM-D.
- •HAM-D item 1 (depressed mood) score ≥
- •Patients must be able to provide written informed consent
- •Patients must be able to speak, read and understand English
Exclusion Criteria
- •Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
- •Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
- •Patients who meet DSM-IV-TR criteria for substance abuse (alcohol or drugs) within 3 months prior to the Screening Visit or substance dependence within 6 months prior to the Screening Visit.
- •Patients who meet criteria for any of the following DSM-IV-TR MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern \[d\]severe with Psychotic Features.
- •Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.
- •Patients who have any one of the following:
- •In the month prior to screening, have had active suicidal ideation with some intent to act, without specific plan.
- •In the month prior to screening, have had suicidal ideation with specific plan and intent.
- •Have made a suicide attempt within the 6 months prior to the screening visit.
- •In the opinion of the Investigator, is currently at significant risk of suicide.
Arms & Interventions
1
vilazodone
Intervention: vilazodone
2
Intervention: placebo
Outcomes
Primary Outcomes
Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.
Time Frame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8
The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
Secondary Outcomes
- Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score(Baseline, week 1, week 2, week 4, week 6, week 8)
- The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8(Week 1, Week 2, Week 4, Week 6, Week 8)
- Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score(Baseline, Week 1, Week 2, Week 4, Week 6, Week 8)
- MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8(Baseline, Week 1, Week 2, Week 4, Week 6, Week 8)
- MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8(Baseline, Week 1, Week 2, Week 4, Week 6, Week 8)