A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

NCT ID: NCT01412060

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 765 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-27
• Study Completion Date: 2014-09-03

Brief Summary

The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

Detailed Description

There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the following criteria to continue in the study.

• Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8
• At least 20% decrease in PANSS total score from baseline to the end of Week 8
• Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8
• Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 8
• Stable dose during the previous 2 weeks
• No significant tolerability issues as judged by the Investigator at the end of Week 8

At the end of the Open-label Phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria:

• PANSS total score ≤ 60 at the end of Week 20
• At least 20% decrease in PANSS total score from baseline to the end of Week 20
• CGI-S score ≤ 4 at the end of Week 20
• Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 20
• No significant tolerability issues as judged by the Investigator During this Double-blind Treatment Phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the Open-label Phase.

All participants entered the 4 week Safety Follow-up Phase. They received a treatment other than the investigational product at the discretion of the Investigator.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Cariprazine - Open-label Phase

Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.

Group Type: EXPERIMENTAL

Cariprazine

Intervention Type: DRUG

Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Placebo - Double-blind Treatment Phase

Participants received placebo orally once a day for 26 to 72 weeks.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo was supplied in capsules.

Cariprazine - Double-blind Treatment Phase

Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks

Group Type: EXPERIMENTAL

Cariprazine

Intervention Type: DRUG

Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Interventions

Placebo

Placebo was supplied in capsules.

Intervention Type: DRUG

Cariprazine

Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Intervention Type: DRUG

Other Intervention Names

RGH-188

Eligibility Criteria

Inclusion Criteria

• 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 schizophrenia.
• Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
• Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
• Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
• Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria

• Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
• Participants in their first episode of psychosis.
• Treatment-resistant schizophrenia over the last 2 years.
• Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
• At imminent risk of injuring self or others or causing significant damage to property.
• Suicide risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gedeon Richter Ltd.

INDUSTRY

Sponsor Role: collaborator

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willie Earley

Role: STUDY_DIRECTOR

Allergan

Locations

Forest Investigative Site 011

Little Rock, Arkansas, United States

Forest Investigative Site 018

Cerritos, California, United States

Forest Investigative Site 007

Costa Mesa, California, United States

Forest Investigative Site 026

Culver City, California, United States

Forest Investigative Site 008

Long Beach, California, United States

Forest Investigative Site 002

Oceanside, California, United States

Forest Investigative Site 019

Orange, California, United States

Forest Investigative Site 001

Paramount, California, United States

Forest Investigative Site 020

San Diego, California, United States

Forest Investigative Site 005

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

Forest Investigative Site 024

Leesburg, Florida, United States

Forest Investigative Site 017

Atlanta, Georgia, United States

Forest Investigative Site 021

Chicago, Illinois, United States

Forest Investigative Site 023

Baltimore, Maryland, United States

Forest Investigative Site 010

Rockville, Maryland, United States

Forest Investigative Site 003

Flowood, Mississippi, United States

Forest Investigative Site 006

Creve Coeur, Missouri, United States

Forest Investigative Site 014

St Louis, Missouri, United States

Forest Investigative Site 012

Cedarhurst, New York, United States

Forest Investigative Site 022

Dayton, Ohio, United States

Forest Investigative Site 015

Austin, Texas, United States

Forest Investigative Site 027

Austin, Texas, United States

Forest Investigative Site 025

Dallas, Texas, United States

Forest Investigative Site 013

Houston, Texas, United States

Forest Investigative Site 009

Houston, Texas, United States

Forest Investigative Site 305

Vijayawada, Andhra Pradesh, India

Forest Investigative Site 303

Ahmedabad, Gujarat, India

Forest Investigative Site 308

Ahmedabad, Gujarat, India

Forest Investigative Site 310

Ahmedabad, Gujarat, India

Forest Investigative Site 313

Mangalore, Karnataka, India

Forest Investigative Site 314

Manipal, Karnataka, India

Forest Investigative Site 301

Aurangabad, Maharashtra, India

Forest Investigative Site 306

Kalyān, Maharashtra, India

Forest Investigative Site 311

Nashik, Maharashtra, India

Forest Investigative Site 317

Jaipur, Rajasthan, India

Forest Investigative Site 302

Jaipur, Rajasthan, India

Forest Investigative Site 312

Madurai, Tamil Nadu, India

Forest Investigative Site 309

Kanpur, Uttar Pradesh, India

Forest Investigative Site 304

Lucknow, Uttar Pradesh, India

Forest Investigative Site 307

Varanasi, Uttar Pradesh, India

Forest Investigative Site 403

Bucharest, , Romania

Forest Investigative Site 405

Bucharest, , Romania

Forest Investigative Site 406

Bucharest, , Romania

Forest Investigative Site 408

Bucharest, , Romania

Forest Investigative Site 410

Bucharest, , Romania

Forest Investigative Site 407

Campulung Muscel, , Romania

Forest Investigative Site 412

Campulung Muscel, , Romania

Forest Investigative Site 402

Constanța, , Romania

Forest Investigative Site 411

Focşani, , Romania

Forest Investigative Site 401

Iași, , Romania

Forest Investigative Site 409

Iași, , Romania

Forest Investigative Site 404

Târgovişte, , Romania

Forest Investigative Site 508

Bratislava, , Slovakia

Forest Investigative Site 507

Bratislava, , Slovakia

Forest Investigative Site 504

Liptovský Mikuláš, , Slovakia

Forest Investigative Site 505

Rimavská Sobota, , Slovakia

Forest Investigative Site 503

Rožňava, , Slovakia

Forest Investigative Site 506

Trnava, , Slovakia

Forest Investigative Site 609

Kerch, AR Crimea, Ukraine

Forest Investigative Site 610

Dnipropetrovsk, , Ukraine

Forest Investigative Site 613

Donetsk, , Ukraine

Forest Investigative Site 616

Ivano-Frankivsk, , Ukraine

Forest Investigative Site 605

Kharkiv, , Ukraine

Forest Investigative Site 606

Kharkiv, , Ukraine

Forest Investigative Site 604

Kharkiv, , Ukraine

Forest Investigative Site 607

Kherson, , Ukraine

Forest Investigative Site 602

Kyiv, , Ukraine

Forest Investigative Site 601

Kyiv, , Ukraine

Forest Investigative Site 612

Kyiv, , Ukraine

Forest Investigative Site 603

Lviv, , Ukraine

Forest Investigative Site 615

Odesa, , Ukraine

Forest Investigative Site 611

Simferopol, , Ukraine

Forest Investigative Site 608

Vinnytsia, , Ukraine

Countries

United States; India; Romania; Slovakia; Ukraine

References

Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.

Reference Type: DERIVED

PMID: 34091867 (View on PubMed)

Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.

Reference Type: DERIVED

PMID: 33854317 (View on PubMed)

Correll CU, Potkin SG, Zhong Y, Harsanyi J, Szatmari B, Earley W. Long-Term Remission With Cariprazine Treatment in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Trial. J Clin Psychiatry. 2019 Jan 8;80(2):18m12495. doi: 10.4088/JCP.18m12495.

Reference Type: DERIVED

PMID: 30695290 (View on PubMed)

Durgam S, Earley W, Li R, Li D, Lu K, Laszlovszky I, Fleischhacker WW, Nasrallah HA. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):264-271. doi: 10.1016/j.schres.2016.06.030. Epub 2016 Jul 15.

Reference Type: DERIVED

PMID: 27427558 (View on PubMed)

Other Identifiers

2011-002048-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RGH-MD-06

Identifier Type: -

Identifier Source: org_study_id