Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 22 April 2013
• Main ID: NCT01469377
• Date of registration: 08/11/2011
• Primary sponsor: Forest Laboratories
• Public title: Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
• Scientific title: A Double-Blind, Placebo-Controlled Study Of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
• Date of first enrolment: December 2011
• Target sample size: 810
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01469377
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Estonia, Finland, Lithuania, Slovakia, Sweden, Ukraine, United States

Contacts

• Name: Sandra Beaird, Pharm.D

• Name: Vinu George, MD
• Affiliation: Forest Laboratories

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female outpatients 18 to 65 years of age, inclusive

- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe MDD

- Current major depressive episode of at least 8 weeks and not exceeding 24 months in
duration

- Ongoing inadequate response to protocol allowed ADT

Exclusion Criteria:

- Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,

- Women who are pregnant, or planning to become pregnant or breastfeed during the study
or not practicing reliable contraception that will continue through out the study

- History of meeting DSM-IV-TR criteria for:

1. Depressive episode with psychotic or catatonic features

2. Manic, hypomanic or mixed episode, including bipolar disorder and substance
induced manic, hypomanic or mixed episode

3. Schizophrenia, schizoaffective, or other psychotic disorder

4. Obsessive-compulsive disorder

5. Bulimia or anorexia nervosa

6. Dementia, amnesic, or other cognitive disorder

7. Mental retardation

- Patients considered a suicide risk



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: cariprazine

Drug: placebo

Primary Outcome(s)

Montgomery-Asberg Depression Rating Scale (MADRS) [Time Frame: 8 Weeks]

Secondary Outcome(s)

Sheehan Disability Scale (SDS) [Time Frame: 8 Weeks]

Secondary ID(s)

RGH-MD-75

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gedeon Richter Ltd.