Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

NCT01396447 | Completed Phase 2 Results

• 2 other identifiers: RGH-MD-562011-002334-39
• Study Type: interventional
• Target: 584
• Locations: 6 countries
• Sites: 88

Brief Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Conditions

Depression, Bipolar

Keywords

Bipolar I disorder; Bipolar depression; Depression; Bipolar disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6

  The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.

  Baseline to Week 6

Secondary Outcomes (1)

• Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6

  Baseline to Week 6

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo orally once a day for 8 weeks.

Drug: Placebo

Cariprazine 0.75 mg

EXPERIMENTAL

Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.

Drug: Cariprazine

Cariprazine 1.5 mg

EXPERIMENTAL

Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.

Drug: Cariprazine

Cariprazine 3.0 mg

EXPERIMENTAL

Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.

Drug: Cariprazine

Interventions

Placebo DRUG

Placebo was supplied in capsules.

Placebo

Cariprazine DRUG

Cariprazine was supplied in capsules.

Cariprazine 0.75 mg; Cariprazine 1.5 mg; Cariprazine 3.0 mg

Eligibility Criteria

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

You may qualify if:

• Participants who have provided informed consent prior to any study specific procedures.
• Participants 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 (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
• Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
• Verified previous manic or mixed episode.
• Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
• Participants with a HAMD-17 item 1 score ≥ 2.
• Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

You may not qualify if:

• Participants 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 6 months.
• Women who are pregnant or breast feeding
• Participants with Young Mania Rating Scale (YMRS) total score \> 10
• Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Sponsors & Collaborators

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

Study Sites (88)

Forest Investigative Site 021

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 017

Springdale, Arkansas, 72764, United States

Location

Forest Investigative Site 030

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site 018

Cerritos, California, 90703, United States

Location

Forest Investigative Site 028

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 015

Oceanside, California, 92056, United States

Location

Forest Investigative Site 011

Temecula, California, 92591, United States

Location

Forest Investigative Site 012

Jacksonville, Florida, 32256, United States

Location

Forest Investigative Site 035

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 013

Winter Park, Florida, 32789, United States

Location

Forest Investigative Site 038

Atlanta, Georgia, 30308, United States

Location

Forest Investigative Site 005

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 029

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site 024

Indianapolis, Indiana, 46260, United States

Location

Forest Investigative Site 031

Prairie Village, Kansas, 66206, United States

Location

Forest Investigative Site 041

Lake Charles, Louisiana, 70629, United States

Location

Forest Investigative Site 040

Shreveport, Louisiana, 71104, United States

Location

Forest Investigative Site 039

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site 026

Creve Coeur, Missouri, 63141, United States

Location

Forest Investigative Site 037

Las Vegas, Nevada, 89102, United States

Location

Forest Investigative Site 023

Cherry Hill, New Jersey, 08002, United States

Location

Forest Investigative Site 014

Marlton, New Jersey, 08053, United States

Location

Forest Investigative Site 006

Albuquerque, New Mexico, 87109, United States

Location

Forest Investigative Site 003

Brooklyn, New York, 11214, United States

Location

Forest Investigative Site 025

New York, New York, 10021, United States

Location

Forest Investigative Site 036

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 008

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 042

Salem, Oregon, 97301, United States

Location

Forest Investigative Site 009

Allentown, Pennsylvania, 18104, United States

Location

Forest Investigative Site 010

Media, Pennsylvania, 19063, United States

Location

Forest Investigative Site 033

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 019

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 007

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 016

Houston, Texas, 77008, United States

Location

Forest Investigative Site 027

Houston, Texas, 77054, United States

Location

Forest Investigative Site 020

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 043

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site 032

Seattle, Washington, 98104, United States

Location

Forest Investigative Site 311

Kardzhali, 6600, Bulgaria

Location

Forest Investigative Site 307

Kazanlak, 6100, Bulgaria

Location

Forest Investigative Site 310

Lovech, 5500, Bulgaria

Location

Forest Investigative Site 313

Novi Iskar, 1282, Bulgaria

Location

Forest Investigative Site 309

Pazardzhik, 4400, Bulgaria

Location

Forest Investigative Site 302

Pleven, 5800, Bulgaria

Location

Forest Investigative Site 301

Plovdiv, 4002, Bulgaria

Location

Forest Investigative Site 305

Sofia, 1431, Bulgaria

Location

Forest Investigative Site 306

Sofia, 1431, Bulgaria

Location

Forest Investigative Site 308

Tsarev Brod, 9747, Bulgaria

Location

Forest Investigative Site 312

Tserova Koria, 5047, Bulgaria

Location

Forest Investigative Site 102

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Forest Investigative Site 103

Penticton, British Columbia, V2A 4M4, Canada

Location

Forest Investigative Site 101

Chatham, Ontario, N7L 5L9, Canada

Location

Forest Investigative Site 804

Barranquilla, Colombia

Location

Forest Investigative Site 806

Barranquilla, Colombia

Location

Forest Investigative Site 803

Bogotá, Colombia

Location

Forest Investigative Site 805

Bogotá, Colombia

Location

Forest Investigative Site 808

Bogotá, Colombia

Location

Forest Investigative Site 807

Pereira, Colombia

Location

Forest Investigative Site 601

Arkhangelsk, 163530, Russia

Location

Forest Investigative Site 605

Moscow, 107076, Russia

Location

Forest Investigative Site 607

Moscow, 115522, Russia

Location

Forest Investigative Site 611

Moscow, 117152, Russia

Location

Forest Investigative Site 619

Moscow, 127083, Russia

Location

Forest Investigative Site 603

Nizhny Novgorod, 603152, Russia

Location

Forest Investigative Site 604

Saint Petersburg, 190005, Russia

Location

Forest Investigative Site 606

Saint Petersburg, 190121, Russia

Location

Forest Investigative Site 602

Saint Petersburg, 191119, Russia

Location

Forest Investigative Site 613

Saint Petersburg, 191119, Russia

Location

Forest Investigative Site 608

Saint Petersburg, 192019, Russia

Location

Forest Investigative Site 615

Saint Petersburg, 192019, Russia

Location

Forest Investigative Site 612

Saint Petersburg, 199034, Russia

Location

Forest Investigative Site 617

Samara, 443016, Russia

Location

Forest Investigative Site 616

Saratov, 410028, Russia

Location

Forest Investigative Site 609

Tomsk, 634014, Russia

Location

Forest Investigative Site 618

Tver', 170005, Russia

Location

Forest Investigative Site 610

Voronezh, 394052, Russia

Location

Forest Investigative Site 707

Kerch, AR Crimea, 98310, Ukraine

Location

Forest Investigative Site 709

Kherson, Vil. Stepanivka, 73488, Ukraine

Location

Forest Investigative Site 714

Donetsk, 83008, Ukraine

Location

Forest Investigative Site 712

Ivano-Frankivsk, 76014, Ukraine

Location

Forest Investigative Site 703

Kharkiv, 61068, Ukraine

Location

Forest Investigative Site 704

Kharkiv, 61068, Ukraine

Location

Forest Investigative Site 702

Kharkiv, 61103, Ukraine

Location

Forest Investigative Site 708

Kyiv, 02660, Ukraine

Location

Forest Investigative Site 701

Kyiv, 04080, Ukraine

Location

Forest Investigative Site 710

Odesa, 65014, Ukraine

Location

Forest Investigative Site 706

Simferopol, 95006, Ukraine

Location

Forest Investigative Site 705

Vinnytsia, 21005, Ukraine

Location

Related Publications (7)

• McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.

  PMID: 39520655 DERIVED

• Vieta E, Calabrese JR, Whelan J, Tohen M, Earley WR. The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial. Curr Med Res Opin. 2021 Sep;37(9):1635-1643. doi: 10.1080/03007995.2021.1932446. Epub 2021 Jun 7.

  PMID: 34034612 DERIVED

• Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.

  PMID: 33915374 DERIVED

• Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.

  PMID: 33677183 DERIVED

• Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.

  PMID: 32942346 DERIVED

• Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.

  PMID: 31969269 DERIVED

• Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, Nemeth G, Vieta E, Calabrese JR, Yatham LN. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016 Mar 1;173(3):271-81. doi: 10.1176/appi.ajp.2015.15020164. Epub 2015 Nov 6.

  PMID: 26541814 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Willie Earley, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 18, 2011
• Study Start: July 26, 2011
• Primary Completion: January 10, 2014
• Study Completion: January 10, 2014
• Last Updated: May 1, 2018
• Results First Posted: May 1, 2018

Record last verified: 2018-03

Locations

US (38); RU (18); UA (12); BU (11); CO (6); CA (3)