Safety and Efficacy of Cariprazine for Mania

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder; Mania

Treatments: Drug: Placebo; Drug: Cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01058096

RGH-MD-32

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Enrollment: 323 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have provided informed consent prior to any study specific procedures
• Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
• Voluntarily hospitalized for current manic episode
• Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion criteria

• Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

323 participants in 2 patient groups, including a placebo group

Cariprazine

Experimental group

Description:

Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.

Treatment:

Drug: Cariprazine

Placebo

Placebo Comparator group

Description:

Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Treatment:

Drug: Placebo