An Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
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|ClinicalTrials.gov Identifier: NCT01715805|
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Cariprazine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||530 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder (MDD)|
|Actual Study Start Date :||November 15, 2012|
|Actual Primary Completion Date :||June 24, 2016|
|Actual Study Completion Date :||June 24, 2016|
Cariprazine, 1.5 milligrams to 4.5 milligrams per day, oral administration.
Patients who meet eligibility will have 1-2 week screening period followed by blind placebo, followed by 8 week double blind treatment period on cariprazine with Antidepressant Therapy (ADT) or placebo with ADT for inadequate responders and ADT with single blind placebo for responders, followed by a 1-week safety follow-up period
Placebo Comparator: Placebo
Dose-matched placebo, onec per day, oral administration
Patients who meet eligibility will have 1-2 week screening period followed by blind placebo, followed by 8 week double blind treatment period on placebo with Antidepressant Therapy (ADT) for inadequate responders and ADT with single blind placebo for responders, followed by a 1-week safety follow-up period
- Montgomery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
- Sheehan Disability Scale [ Time Frame: 8 weeks ]The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe).
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): NCT01715805
Show 85 Study Locations
|Study Director:||Willie Earley, MD||Allergan|