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

NCT01412060 | Completed Phase 3 Results

• 2 other identifiers: RGH-MD-062011-002048-29
• Study Type: interventional
• Target: 765
• Locations: 5 countries
• Sites: 73

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Schizophrenic disorder

Outcome Measures

Primary Outcomes (1)

• Time From Baseline to the First Symptom Relapse During the Double-blind Phase

  Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion. PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.

  Up to 34 Weeks and Bi-Weekly thereafter until Week 92

Study Arms (3)

Cariprazine - Open-label Phase

EXPERIMENTAL

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.

Drug: Cariprazine

Placebo - Double-blind Treatment Phase

EXPERIMENTAL

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

Drug: Placebo

Cariprazine - Double-blind Treatment Phase

EXPERIMENTAL

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

Drug: Cariprazine

Interventions

Placebo DRUG

Placebo was supplied in capsules.

Placebo - Double-blind Treatment Phase

Cariprazine DRUG

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

Also known as: RGH-188

Cariprazine - Double-blind Treatment Phase; Cariprazine - Open-label Phase

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (73)

Forest Investigative Site 011

Little Rock, Arkansas, 72211, United States

Location

Forest Investigative Site 018

Cerritos, California, 90703, United States

Location

Forest Investigative Site 007

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 026

Culver City, California, 90230, United States

Location

Forest Investigative Site 008

Long Beach, California, 90813, United States

Location

Forest Investigative Site 002

Oceanside, California, 92056, United States

Location

Forest Investigative Site 019

Orange, California, 92868, United States

Location

Forest Investigative Site 001

Paramount, California, 90723, United States

Location

Forest Investigative Site 020

San Diego, California, 92123, United States

Location

Forest Investigative Site 005

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

Location

Forest Investigative Site 024

Leesburg, Florida, 34748, United States

Location

Forest Investigative Site 017

Atlanta, Georgia, 30331, United States

Location

Forest Investigative Site 021

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site 023

Baltimore, Maryland, 21202, United States

Location

Forest Investigative Site 010

Rockville, Maryland, 20850, United States

Location

Forest Investigative Site 003

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site 006

Creve Coeur, Missouri, 63141, United States

Location

Forest Investigative Site 014

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 012

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 022

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 015

Austin, Texas, 78731, United States

Location

Forest Investigative Site 027

Austin, Texas, 78754, United States

Location

Forest Investigative Site 025

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 013

Houston, Texas, 77008, United States

Location

Forest Investigative Site 009

Houston, Texas, 77021, United States

Location

Forest Investigative Site 305

Vijayawada, Andhra Pradesh, 520002, India

Location

Forest Investigative Site 303

Ahmedabad, Gujarat, 380006, India

Location

Forest Investigative Site 308

Ahmedabad, Gujarat, 380006, India

Location

Forest Investigative Site 310

Ahmedabad, Gujarat, 380015, India

Location

Forest Investigative Site 313

Mangalore, Karnataka, 575018, India

Location

Forest Investigative Site 314

Manipal, Karnataka, 576104, India

Location

Forest Investigative Site 301

Aurangabad, Maharashtra, 431005, India

Location

Forest Investigative Site 306

Kalyān, Maharashtra, 421301, India

Location

Forest Investigative Site 311

Nashik, Maharashtra, 422101, India

Location

Forest Investigative Site 317

Jaipur, Rajasthan, 302021, India

Location

Forest Investigative Site 302

Jaipur, Rajasthan, 303706, India

Location

Forest Investigative Site 312

Madurai, Tamil Nadu, 625020, India

Location

Forest Investigative Site 309

Kanpur, Uttar Pradesh, 208005, India

Location

Forest Investigative Site 304

Lucknow, Uttar Pradesh, 226003, India

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Forest Investigative Site 307

Varanasi, Uttar Pradesh, 221005, India

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Forest Investigative Site 403

Bucharest, 041914, Romania

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Forest Investigative Site 405

Bucharest, 041914, Romania

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Forest Investigative Site 406

Bucharest, 041914, Romania

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Forest Investigative Site 408

Bucharest, 041914, Romania

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Forest Investigative Site 410

Bucharest, 041914, Romania

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Forest Investigative Site 407

Campulung Muscel, 115100, Romania

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Forest Investigative Site 412

Campulung Muscel, 115100, Romania

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Forest Investigative Site 402

Constanța, 900002, Romania

Location

Forest Investigative Site 411

Focşani, 620165, Romania

Location

Forest Investigative Site 401

Iași, 700282, Romania

Location

Forest Investigative Site 409

Iași, 700282, Romania

Location

Forest Investigative Site 404

Târgovişte, 130086, Romania

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Forest Investigative Site 508

Bratislava, 81369, Slovakia

Location

Forest Investigative Site 507

Bratislava, 82606, Slovakia

Location

Forest Investigative Site 504

Liptovský Mikuláš, 03125, Slovakia

Location

Forest Investigative Site 505

Rimavská Sobota, 97912, Slovakia

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Forest Investigative Site 503

Rožňava, 04801, Slovakia

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Forest Investigative Site 506

Trnava, 91701, Slovakia

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Forest Investigative Site 609

Kerch, AR Crimea, 98310, Ukraine

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Forest Investigative Site 610

Dnipropetrovsk, 49115, Ukraine

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Forest Investigative Site 613

Donetsk, 83008, Ukraine

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Forest Investigative Site 616

Ivano-Frankivsk, 76014, Ukraine

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Forest Investigative Site 605

Kharkiv, 61068, Ukraine

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Forest Investigative Site 606

Kharkiv, 61068, Ukraine

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Forest Investigative Site 604

Kharkiv, 61103, Ukraine

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Forest Investigative Site 607

Kherson, 73488, Ukraine

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Forest Investigative Site 602

Kyiv, 02660, Ukraine

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Forest Investigative Site 601

Kyiv, 04080, Ukraine

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Forest Investigative Site 612

Kyiv, 04080, Ukraine

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Forest Investigative Site 603

Lviv, 79021, Ukraine

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Forest Investigative Site 615

Odesa, 65014, Ukraine

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Forest Investigative Site 611

Simferopol, 95006, Ukraine

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Forest Investigative Site 608

Vinnytsia, 21005, Ukraine

Location

Related Publications (4)

• 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.

  PMID: 34091867 DERIVED

• 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.

  PMID: 33854317 DERIVED

• 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.

  PMID: 30695290 DERIVED

• 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.

  PMID: 27427558 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Willie Earley

  Allergan

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: September 27, 2011
• Primary Completion: September 3, 2014
• Study Completion: September 3, 2014
• Last Updated: July 6, 2018
• Results First Posted: July 6, 2018

Record last verified: 2018-06

Locations

UA (15); RO (12); US (25); IN (15); SL (6)