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SchizophreniaPhase 3NCT01412060

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

A Phase 3 study testing Cariprazine in people with Schizophrenia, run by Forest Laboratories at 73 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Cariprazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
765 participants
Where
73 sitesin 5 countries
Study dates
27 Sep 2011to 3 Sep 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

73 sites in 5 countries.

73 sites in 5 countries

United States25 sites

  • Forest Investigative Site 017

    Atlanta, Georgia, 30331

  • Forest Investigative Site 015

    Austin, Texas, 78731

  • Forest Investigative Site 027

    Austin, Texas, 78754

  • Forest Investigative Site 023

    Baltimore, Maryland, 21202

  • Forest Investigative Site 012

    Cedarhurst, New York, 11516

  • Forest Investigative Site 018

    Cerritos, California, 90703

  • Forest Investigative Site 021

    Chicago, Illinois, 60640

  • Forest Investigative Site 007

    Costa Mesa, California, 92626

  • Forest Investigative Site 006

    Creve Coeur, Missouri, 63141

  • Forest Investigative Site 026

    Culver City, California, 90230

  • Forest Investigative Site 025

    Dallas, Texas, 75231

  • Forest Investigative Site 022

    Dayton, Ohio, 45417

  • Forest Investigative Site 003

    Flowood, Mississippi, 39232

  • Forest Investigative Site 013

    Houston, Texas, 77008

  • Forest Investigative Site 009

    Houston, Texas, 77021

  • Forest Investigative Site 024

    Leesburg, Florida, 34748

  • Forest Investigative Site 011

    Little Rock, Arkansas, 72211

  • Forest Investigative Site 008

    Long Beach, California, 90813

  • Forest Investigative Site 002

    Oceanside, California, 92056

  • Forest Investigative Site 019

    Orange, California, 92868

  • Forest Investigative Site 001

    Paramount, California, 90723

  • Forest Investigative Site 010

    Rockville, Maryland, 20850

  • Forest Investigative Site 020

    San Diego, California, 92123

  • Forest Investigative Site 014

    St Louis, Missouri, 63141

  • Forest Investigative Site 005

    Washington D.C., District of Columbia, 20016

Other trials in United States

India15 sites

  • Forest Investigative Site 303

    Ahmedabad, Gujarat, 380006

  • Forest Investigative Site 308

    Ahmedabad, Gujarat, 380006

  • Forest Investigative Site 310

    Ahmedabad, Gujarat, 380015

  • Forest Investigative Site 301

    Chhatrapati Sambhajinagar, Maharashtra, 431005

  • Forest Investigative Site 317

    Jaipur, Rajasthan, 302021

  • Forest Investigative Site 302

    Jaipur, Rajasthan, 303706

  • Forest Investigative Site 306

    Kalyān, Maharashtra, 421301

  • Forest Investigative Site 309

    Kanpur, Uttar Pradesh, 208005

  • Forest Investigative Site 304

    Lucknow, Uttar Pradesh, 226003

  • Forest Investigative Site 312

    Madurai, Tamil Nadu, 625020

  • Forest Investigative Site 313

    Mangalore, Karnataka, 575018

  • Forest Investigative Site 314

    Manipal, Karnataka, 576104

  • Forest Investigative Site 311

    Nashik, Maharashtra, 422101

  • Forest Investigative Site 307

    Varanasi, Uttar Pradesh, 221005

  • Forest Investigative Site 305

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

Ukraine15 sites

  • Forest Investigative Site 610

    Dnipropetrovsk, 49115

  • Forest Investigative Site 613

    Donetsk, 83008

  • Forest Investigative Site 616

    Ivano-Frankivsk, 76014

  • Forest Investigative Site 609

    Kerch, AR Crimea, 98310

  • Forest Investigative Site 605

    Kharkiv, 61068

  • Forest Investigative Site 606

    Kharkiv, 61068

  • Forest Investigative Site 604

    Kharkiv, 61103

  • Forest Investigative Site 607

    Kherson, 73488

  • Forest Investigative Site 602

    Kyiv, 02660

  • Forest Investigative Site 601

    Kyiv, 04080

  • Forest Investigative Site 612

    Kyiv, 04080

  • Forest Investigative Site 603

    Lviv, 79021

  • Forest Investigative Site 615

    Odesa, 65014

  • Forest Investigative Site 611

    Simferopol, 95006

  • Forest Investigative Site 608

    Vinnytsia, 21005

Other trials in Ukraine

Romania12 sites

  • Forest Investigative Site 403

    Bucharest, 041914

  • Forest Investigative Site 405

    Bucharest, 041914

  • Forest Investigative Site 406

    Bucharest, 041914

  • Forest Investigative Site 408

    Bucharest, 041914

  • Forest Investigative Site 410

    Bucharest, 041914

  • Forest Investigative Site 407

    Campulung Muscel, 115100

  • Forest Investigative Site 412

    Campulung Muscel, 115100

  • Forest Investigative Site 402

    Constanța, 900002

  • Forest Investigative Site 411

    Focşani, 620165

  • Forest Investigative Site 401

    Iași, 700282

  • Forest Investigative Site 409

    Iași, 700282

  • Forest Investigative Site 404

    Targoviste, 130086

Other trials in Romania

Slovakia6 sites

  • Forest Investigative Site 508

    Bratislava, 81369

  • Forest Investigative Site 507

    Bratislava, 82606

  • Forest Investigative Site 504

    Liptovský Mikuláš, 03125

  • Forest Investigative Site 505

    Rimavská Sobota, 97912

  • Forest Investigative Site 503

    Rožňava, 04801

  • Forest Investigative Site 506

    Trnava, 91701

Other trials in Slovakia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

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.

Read the 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
Being tested
Placebo, Cariprazine
Keywords
Schizophrenia, Schizophrenic disorder
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo was supplied in capsules.

  • CariprazineDrug

    Also called RGH-188

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

Study groups in NCT01412060
Study groupRoleWhat they receive
Cariprazine - Open-label PhaseExperimentalParticipants 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.
Receives: Drug: Cariprazine
Placebo - Double-blind Treatment PhaseExperimentalParticipants received placebo orally once a day for 26 to 72 weeks.
Receives: Drug: Placebo
Cariprazine - Double-blind Treatment PhaseExperimentalParticipants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
Receives: Drug: Cariprazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2011 (estimated)
  2. Study start27 Sep 2011
  3. Primary completion3 Sep 2014
  4. Study completion3 Sep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
765 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412060
Sponsor's protocol ID
RGH-MD-06
Other IDs
2011-002048-29
Status last verified
Jun 2018
First submitted
4 Aug 2011
Last updated
6 Jul 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 34091867

  • 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.

    PubMed 33854317

  • 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.

    PubMed 30695290

  • 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.

    PubMed 27427558

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Schizophrenia, run by Forest Laboratories at 73 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, India, Ukraine, Romania, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Baseline to the First Symptom Relapse During the Double-blind Phase (time frame: Up to 34 Weeks and Bi-Weekly thereafter until Week 92). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01412060, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.

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