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Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03593213
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
  1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared with placebo in prevention of relapse in patients with schizophrenia
  2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Cariprazine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : June 7, 2021
Estimated Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cariprazine 3.0 mg/day
Cariprazine capsules, oral administration, once daily.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.

Experimental: Cariprazine 4.5 mg/day
Cariprazine capsules, oral administration, once daily.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.

Placebo Comparator: Placebo
Matching placebo capsules, oral administration, once daily.
Drug: Placebo
Matching placebo capsules, oral administration, once daily.




Primary Outcome Measures :
  1. The primary efficacy parameter is the time to first relapse during the DB treatment period, defined as the number of days from the randomization date to the first relapse date. [ Time Frame: From Visit 11 (Week 14) up to Visit 26 (Week 44) ]

    Relapse is defined as the occurrence of any 1 of the following:

    • Increase in PANSS total score by ≥ 30% for patients who had a PANSS total score of

      ≥ 50 at Randomization/Visit 13 or a ≥ 10-point increase in PANSS total score for patients who had a PANSS total score < 50 at Randomization/Visit 13

    • Increase in CGI-S score by 2 or more points relative to Randomization/Visit 13
    • Score of > 4 on 1 or more of the following 7 PANSS items: P1; P2; P3; P6; P7; G8; G14
    • Deliberate self-injury or aggressive/violent behavior
    • Initiation of treatment with a mood stabilizer, antidepressant, antipsychotic agent, or with a benzodiazepine exceeding protocol-specified allowance to treat worsening symptoms of schizophrenia/any other psychiatric disorder as judged by the investigator
    • Psychiatric hospitalization due to worsening of the underlying condition
    • Exacerbation of psychiatric illness as judged by the investigator



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.
  • Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
  • Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.
  • PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
  • Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behavior; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

  • Currently meeting DSM-5 criteria for any of the following:
  • Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
  • Bipolar I and II disorder
  • Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
  • History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
  • Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
  • Female patients who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593213


Contacts
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Contact: Clinical Trials Registry Team 877‐277‐8566 IR‐CTRegistration@Allergan.com

  Show 117 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Regan Dickinson Allergan

Additional Information:
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT03593213     History of Changes
Other Study ID Numbers: RGH-MD-24
2017-000818-34 ( EudraCT Number )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cariprazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs