Safety and Efficacy of Cariprazine for Mania

NCT01058096 | Completed Phase 3 Results

• 1 other identifier: RGH-MD-32
• Study Type: interventional
• Target: 323
• Locations: 2 countries
• Sites: 28

Brief Summary

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.

Conditions

Bipolar Disorder; Mania

Keywords

Acute Mania; Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3

  The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.

  Baseline, Week 3

Secondary Outcomes (1)

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3

  Baseline, Week 3

Study Arms (2)

Cariprazine

EXPERIMENTAL

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

Drug: Cariprazine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cariprazine DRUG

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.

Cariprazine

Placebo DRUG

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Forest Laboratories: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (28)

Forest Investigative Site 004

Long Beach, California, 90813, United States

Location

Forest Investigative Site 005

Riverside, California, 92506, United States

Location

Forest Investigative Site 007

San Diego, California, 92123, United States

Location

Forest Investigative Site 009

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site 006

Lake Charles, Louisiana, 70601, United States

Location

Forest Investigative Site 001

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site 003

Creve Couer, Missouri, 63141, United States

Location

Forest Investigative Site 008

Cleveland, Ohio, 44109, United States

Location

Forest Investigative Site 010

Oklahoma City, Oklahoma, 73116, United States

Location

Forest Investigative Site 002

Houston, Texas, 77008, United States

Location

Forest Investigative Site 106

Vijayawada, Andhra Pradesh, 520002, India

Location

Forest Investigative Site 112

Vizag, Andhra Pradesh, 530017, India

Location

Forest Investigator Site 108

Varanasi, Durgakund, 221005, India

Location

Forest Investigative Site 103

Ahmedabad, Gujarat, 380013, India

Location

Forest Investigative Site 120

Ahmedabad, Gujarat, 380015, India

Location

Forest Investigative Site 105

Bangalore, Karnataka, 560010, India

Location

Forest Investigative Site 107

Bangalore, Karnataka, 560027, India

Location

Forest Investigative Site 118

Mangalore, Karnataka, 575001, India

Location

Forest Investigative Site 113

Mangalore, Karnataka, 575018, India

Location

Forest Investigative Site 115

Manipal, Karnataka, 576104, India

Location

Forest Investigative Site 114

Mysore, Karnataka, 570004, India

Location

Forest Investigative Site 101

Aurangabad, Maharashtra, 431005, India

Location

Forest Investigative Site 110

Nashik, Maharashtra, 422101, India

Location

Forest Investigative Site 111

Pune, Maharashtra, 411004, India

Location

Forest Investigative Site 104

Pune, Maharashtra, 411030, India

Location

Forest Investigative Site 121

Chennai, Tamil Nadu, 600003, India

Location

Forest Investigative Site 109

Kanpur, Uttar Pradesh, 200005, India

Location

Forest Investigative Site 119

Lucknow, Uttar Pradesh, 226006, India

Location

Related Publications (2)

• McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.

  PMID: 31344528 DERIVED

• Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.

  PMID: 29017067 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

All participants from 1 investigative site are excluded due to GCP violations.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

714-246-4500

Study Officials

• Elizabeth Diaz, MD

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-03

Locations

US (10); IN (18)