Clinical Trials List
Protocol NumberRGH-MD-24
NCT Number(ClinicalTrials.gov Identfier)NCT03593213
2019-10-01 - 2021-01-26
Phase III
Not yet recruiting2
Study ended1
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.
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Allergan
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- T.P. SU Division of Psychiatry
- Ya-Mei Bai Division of Psychiatry
- 周昱百 Division of Psychiatry
- Mei-Ju Chen Division of Psychiatry
- W. C. LIN Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Schizophrenia
Objectives
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
Test Drug
Cariprazine
Active Ingredient
Cariprazine
Dosage Form
Capsule
Dosage
1.5m, 3.0 mg, 4.5 mg
Endpoints
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.
Relapse is defined as the occurrence of any 1 of the following:
(1) 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
(2) Increase in CGI-S score by 2 or more points relative to Randomization/Visit 13
(3) Score of > 4 on 1 or more of the following 7 PANSS items: P1; P2; P3; P6; P7; G8; G14
(4) Deliberate self-injury or aggressive/violent behavior
(5) 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
(6) Psychiatric hospitalization due to worsening of the underlying condition
(7) Exacerbation of psychiatric illness as judged by the investigator
Relapse is defined as the occurrence of any 1 of the following:
(1) 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
(2) Increase in CGI-S score by 2 or more points relative to Randomization/Visit 13
(3) Score of > 4 on 1 or more of the following 7 PANSS items: P1; P2; P3; P6; P7; G8; G14
(4) Deliberate self-injury or aggressive/violent behavior
(5) 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
(6) Psychiatric hospitalization due to worsening of the underlying condition
(7) Exacerbation of psychiatric illness as judged by the investigator
Inclution Criteria
1. Diagnosis of schizophrenia for a minimum of 1 year before Visit 1.
2. 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.
3. Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.
4. PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
5. 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.
2. 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.
3. Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.
4. PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2.
5. 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
1. Currently meeting DSM-5 criteria for any of the following:
2. Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
3. Bipolar I and II disorder
4. Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
5. 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.
6. Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
7. Female patients who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
2. Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
3. Bipolar I and II disorder
4. Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
5. 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.
6. Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
7. Female patients who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
1035 participants
