Safety and Efficacy of Cariprazine for Bipolar I Disorder

NCT01058668 | Completed Phase 3 Results

• 1 other identifier: RGH-MD-33
• Study Type: interventional
• Target: 497
• Locations: 6 countries
• Sites: 66

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

Mania; Bipolar I Disorder

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 five-point scale (0-4) and 4-items on a nine-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 is a mixed model for repeated measurements (MMRM) using observed cases, 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 (3)

Cariprazine (3-6 mg/day)

EXPERIMENTAL

Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.

Drug: Cariprazine

Cariprazine (6-12 mg/day)

EXPERIMENTAL

Cariprazine 6 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 for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Cariprazine (3-6 mg/day); Cariprazine (6-12 mg/day)

Placebo DRUG

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

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 (66)

Forest Investigative Site 018

Little Rock, Arkansas, 72211, United States

Location

Forest Investigative Site 012

Cerritos, California, 90703, United States

Location

Forest Investigative Site 010

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 005

Oceanside, California, 92056, United States

Location

Forest Investigative Site 023

San Diego, California, 92102, United States

Location

Forest Investigative Site 017

San Diego, California, 92103, United States

Location

Forest Investigative Site 024

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 016

New Britain, Connecticut, 06050, United States

Location

Forest Investigative Site 007

Washington D.C., District of Columbia, 20016, United States

Location

Forest Investigative Site 002

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 003

Orlando, Florida, 32821, United States

Location

Forest Investigative Site 026

Atlanta, Georgia, 30308, United States

Location

Forest Investigative Site 013

Honolulu, Hawaii, 96813, United States

Location

Forest Investigative Site 011

Hoffman Estates, Illinois, 60169, United States

Location

Forest Investigative Site 021

Greenwood, Indiana, 46143, United States

Location

Forest Investigative Site 001

Shreveport, Louisiana, 71115, United States

Location

Forest Investigative Site 006

Rockville, Maryland, 20850, United States

Location

Forest Investigative Site 025

St Louis, Missouri, 63118, United States

Location

Forest Investigative Site 008

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 019

Philadelphia, Pennsylvania, 19139, United States

Location

Forest Investigative Site 015

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 004

Irving, Texas, 75062, United States

Location

Forest Investigative Site 014

Bothell, Washington, 98011, United States

Location

Forest Investigative Site 607

Rijeka, 51 000, Croatia

Location

Forest Investigative Site 602

Zagreb, 10 000, Croatia

Location

Forest Investigative Site 605

Zagreb, 10 000, Croatia

Location

Forest Investigative Site 606

Zagreb, 10 090, Croatia

Location

Forest Investigative Site 210

Craiova, Dolj, 200745, Romania

Location

Forest Investigative Site 204

Târgovişte, Dâmbovița County, 130086, Romania

Location

Forest Investigative Site 211

Timișoara, Timiș County, 300182, Romania

Location

Forest Investigative Site 212

Focşani, Vrancea, 620165, Romania

Location

Forest Investigative Site 209

Arad, 310022, Romania

Location

Forest Investigative Site 203

Bucharest, 041915, Romania

Location

Forest Investigative Site 205

Bucharest, 041915, Romania

Location

Forest Investigative Site 206

Bucharest, 041915, Romania

Location

Forest Investigative Site 208

Bucharest, 041915, Romania

Location

Forest Investigative Site 202

Constanța, 900002, Romania

Location

Forest Investigative Site 201

Craiova, 200260, Romania

Location

Forest Investigative Site 501

Lipetsk, 398007, Russia

Location

Forest Investigative Site 503

Moscow, 115522, Russia

Location

Forest Investigative Site 507

Moscow, 115522, Russia

Location

Forest Investigative Site 510

Moscow, 115522, Russia

Location

Forest Investigative Site 506

Saint Petersburg, 190005, Russia

Location

Forest Investigative Site 508

Saint Petersburg, 190121, Russia

Location

Forest Investigative Site 509

Samara, 443016, Russia

Location

Forest Investigative Site 504

Saratov, 410028, Russia

Location

Forest Investigative Site 502

Smolensk, 214019, Russia

Location

Forest Investigative Site 403

Belgrade, 11000, Serbia

Location

Forest Investigative Site 404

Belgrade, 11000, Serbia

Location

Forest Investigative Site 405

Belgrade, 11000, Serbia

Location

Forest Investigative Site 402

Kragujevac, 34000, Serbia

Location

Forest Investigative Site 401

Senta, 24400, Serbia

Location

Forest Investigative Site 308

Dnipropetrovsk, 49027, Ukraine

Location

Forest Investigative Site 315

Dnipropetrovsk, 49115, Ukraine

Location

Forest Investigative Site 301

Donetsk, 83008, Ukraine

Location

Forest Investigative Site 307

Kharkiv, 61068, Ukraine

Location

Forest Investigative Site 310

Kharkiv, 61068, Ukraine

Location

Forest Investigative Site 304

Kyiv, 01030, Ukraine

Location

Forest Investigative Site 305

Kyiv, 02660, Ukraine

Location

Forest Investigative Site 303

Kyiv, 04080, Ukraine

Location

Forest Investigative Site 309

Kyiv, 04080, Ukraine

Location

Forest Investigative Site 312

Kyiv, 08631, Ukraine

Location

Forest Investigative Site 306

Luhansk, 91045, Ukraine

Location

Forest Investigative Site 311

Lviv, 79021, Ukraine

Location

Forest Investigative Site 302

Odesa, 65006, Ukraine

Location

Forest Investigative Site 314

Poltava, 36006, Ukraine

Location

Related Publications (3)

• 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

• Calabrese JR, Keck PE Jr, Starace A, Lu K, Ruth A, Laszlovszky I, Nemeth G, Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.

  PMID: 25562205 DERIVED

MeSH Terms

Conditions

Mania

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

All participants from 1 investigative site were excluded due to Good Clinical Practice (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 29, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 12, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-03

Locations

SE (5); CR (4); RO (11); US (23); UA (14); RU (9)