A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01412060 |
|
Recruitment Status :
Completed
First Posted : August 8, 2011
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Placebo Drug: Cariprazine | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 765 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase |
| Primary Purpose: | Prevention |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia |
| Actual Study Start Date : | September 27, 2011 |
| Actual Primary Completion Date : | September 3, 2014 |
| Actual Study Completion Date : | September 3, 2014 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
Drug: Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other Name: RGH-188 |
|
Experimental: Placebo - Double-blind Treatment Phase
Participants received placebo orally once a day for 26 to 72 weeks.
|
Drug: Placebo
Placebo was supplied in capsules. |
|
Experimental: Cariprazine - Double-blind Treatment Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
|
Drug: Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other Name: RGH-188 |
- 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 ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT01412060
Show 73 study locations
| Study Director: | Willie Earley | Allergan |
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01412060 |
| Other Study ID Numbers: |
RGH-MD-06 2011-002048-29 ( EudraCT Number ) |
| First Posted: | August 8, 2011 Key Record Dates |
| Results First Posted: | July 6, 2018 |
| Last Update Posted: | July 6, 2018 |
| Last Verified: | June 2018 |
|
Schizophrenia Schizophrenic disorder |
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Cariprazine Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |