Safety and Efficacy of Cariprazine for Mania

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Mania

In brief

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.

Key facts

Study ID

NCT01058096

Run by

Forest Laboratories

People needed

323

Starts

2010-02-01

Expected to finish

2011-07-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 004 — Long Beach, California, United States
• Forest Investigative Site 005 — Riverside, California, United States
• Forest Investigative Site 007 — San Diego, California, United States
• Forest Investigative Site 009 — Chicago, Illinois, United States
• Forest Investigative Site 006 — Lake Charles, Louisiana, United States
• Forest Investigative Site 001 — Flowood, Mississippi, United States
• Forest Investigative Site 003 — Creve Couer, Missouri, United States
• Forest Investigative Site 008 — Cleveland, Ohio, United States
• Forest Investigative Site 010 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 002 — Houston, Texas, United States
• Forest Investigative Site 106 — Vijayawada, Andhra Pradesh, India
• Forest Investigative Site 112 — Vizag, Andhra Pradesh, India
• Forest Investigator Site 108 — Varanasi, Durgakund, India
• Forest Investigative Site 103 — Ahmedabad, Gujarat, India
• Forest Investigative Site 120 — Ahmedabad, Gujarat, India
• Forest Investigative Site 105 — Bangalore, Karnataka, India
• Forest Investigative Site 107 — Bangalore, Karnataka, India
• Forest Investigative Site 118 — Mangalore, Karnataka, India
• Forest Investigative Site 113 — Mangalore, Karnataka, India
• Forest Investigative Site 115 — Manipal, Karnataka, India
• Forest Investigative Site 114 — Mysore, Karnataka, India
• Forest Investigative Site 101 — Aurangabad, Maharashtra, India
• Forest Investigative Site 110 — Nashik, Maharashtra, India
• Forest Investigative Site 111 — Pune, Maharashtra, India
• Forest Investigative Site 104 — Pune, Maharashtra, India

Full record on ClinicalTrials.gov

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