Clinical Trials Logo
  1. Home
  2. Schizophrenia
  3. NCT01104779
  4. Details
NCT01104779 Clinical Trial

Safety and Efficacy of Cariprazine in Schizophrenia

Schizophrenia Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01104779
Other study ID # RGH-MD-05
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 27, 2010
Est. completion date December 15, 2011

Study information
Verified date October 2018
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Recruitment information / eligibility
Status Completed
Enrollment 446
Est. completion date December 15, 2011
Est. primary completion date December 15, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients who have provided informed consent prior to any study specific procedures

- Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)

- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score = 80 and = 120

- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1

- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

- Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

- Patients in their first episode of psychosis

- Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study

- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders

- Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study

- Substance abuse or dependence within the prior 3 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
• Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Locations
Country Name City State
Colombia Forest Investigative Site 601 Bello Antioquia
Colombia Forest Investigative Site 602 Bogota
Colombia Forest Investigative Site 605 Bogota
Colombia Forest Investigative Site 604 Pereira Risaralda
India Forest Investigative Site 501 Ahmedabad Gujarat
India Forest Investigative Site 503 Ahmedabad Gujarat
India Forest Investigative Site 508 Ahmedabad Gujarat
India Forest Investigative Site 519 Ahmedabad Gujarat
India Forest Investigative Site 500 Aurangabad Mahara
India Forest Investigative Site 504 Bangalore Karna
India Forest Investigative Site 507 Kanpur Uttar Pradesh
India Forest Investigative Site 518 Lucknow Uttar Pradesh
India Forest Investigative Site 515 Mangalore Karna
India Forest Investigative Site 517 Mangalore Karna
India Forest Investigative Site 510 Mumbai Mahara
India Forest Investigative Site 516 Mysore Karna
India Forest Investigative Site 513 Nashik Mahara
India Forest Investigative Site 502 Pune Mahara
India Forest Investigative Site 511 Pune Mahara
India Forest Investigative Site 509 Rajkot Rajastan
India Forest Investigative Site 506 Varanasi Uttar Pradesh
India Forest Investigative Site 505 Vijayawada Andhra Pradesh
India Forest Investigative Site 514 Visakhapatnam Andhra Pradesh
South Africa Forest Investigative Site 703 Cape Town W Cape
South Africa Forest Investigative Site 706 Cape Town W Cape
South Africa Forest Investigative Site 704 Johannesburg Gauteng
United States Forest Investigative Site 055 Atlanta Georgia
United States Forest Investigative Site 40 Cedarhurst New York
United States Forest Investigative Site 46 Cincinnati Ohio
United States Forest Investigative Site 48 Costa Mesa California
United States Forest Investigative Site 51 Houston Texas
United States Forest Investigative Site 43 Irving Texas
United States Forest Investigative Site 41 Kissimmee Florida
United States Forest Investigative Site 52 Las Vegas Nevada
United States Forest Investigative Site 50 Long Beach California
United States Forest Investigative 49 Memphis Tennessee
United States Forest Investigative Site 42 Paramount California
United States Forest Investigative Site 47 Philadelphia Pennsylvania
United States Forest Investigative Site 44 Rockville Maryland
United States Forest Investigative Site 45 Saint Louis Missouri
United States Forest Investigative Site 054 San Diego California

Sponsors (2)
Lead Sponsor Collaborator
Forest Laboratories Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Colombia,  India,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement. Baseline to Week 6
Secondary Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S) The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement. Baseline to Week 6
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A