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Cariprazine 1.5 mg/day + ADT for Depression

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 6

Awards & highlights

Pivotal Trial

Summary

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.

Eligible Conditions

Depression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mental Depression

Secondary study objectives

Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cariprazine 3 mg/day + ADTExperimental Treatment2 Interventions

Cariprazine 1.5 mg capsules, orally, once daily for 2 weeks starting at the Baseline, titrated to 3.0 mg capsules, orally, once daily from Week 2 through Week 6 in addition to their ongoing ADT (same antidepressant and dose of ADT) during the Double-blind Treatment Period, up to Week 6.

Group II: Cariprazine 1.5 mg/day + ADTExperimental Treatment2 Interventions

Cariprazine 1.5 mg capsules, orally, once daily in addition to their ongoing ADT (same antidepressant and dose of ADT they were on at the Baseline) during the Double-blind Treatment Period, up to Week 6.

Group III: Placebo + ADTPlacebo Group2 Interventions

Cariprazine matching placebo capsules, orally, once daily in addition to their ongoing antidepressant therapy (ADT) \[same antidepressant and dose of ADT they were on at the Baseline\] during the Double-blind Treatment Period, up to Week 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antidepressant Therapy (ADT)

2013

Completed Phase 3

~2220

Cariprazine

2010

Completed Phase 3

~11050