NCT01838876

Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

A Phase 3, Long-term, Open-label Study of Safety and Tolerability of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Cariprazine	Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.
DRUG	Antidepressant Therapy (ADT)	ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug

Timeline

• Start date: 2013-04-29
• Primary completion: 2015-07-27
• Completion: 2015-07-27
• First posted: 2013-04-24
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

90 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study