Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
1 other identifier
interventional
375
1 country
1
Brief Summary
This is a study designed to evalute the safety and efficacy of RGH-188 in the treatment of acute schizophrenia. This study will be 10 weeks in duration; 6 weeks double-blind treatment, and 4 weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of the three treatment groups--one of two doses of RGH-188 or placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 27, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedJanuary 7, 2008
January 1, 2008
9 months
November 27, 2006
January 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PANSS Total Score
Secondary Outcomes (1)
CGI-S
Interventions
Eligibility Criteria
You may qualify if:
- Male and female inpatients, 18-65 years of age, meeting DSM-IV-TR criteria for schizophrenia and having a Total Positive and Negative Syndrome Scale (PANSS) Score \>=80 and \<=120. A score \>=4 on item P1 (delusions) or P3 (hallucinatory behavior) and a score of \>=4 on item P2 (conceptual disorganization) or P6 (suspiciousness/persecution) of the PNASS
You may not qualify if:
- Patients with documented disease of the central nervous system that can interfere with the trial assessments, including but not limited to stroke, tumor, Parkinson's, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who have suffered a traumatic brain injury resulting in significant impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
For information regarding investigative sites, contact Forest Professional Affairs
St Louis, Missouri, 63045, United States
Related Publications (3)
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.
PMID: 34091867DERIVEDBarabassy 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.
PMID: 33854317DERIVEDEarley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
PMID: 28692485DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 27, 2006
First Posted
November 29, 2006
Study Start
November 1, 2006
Primary Completion
August 1, 2007
Last Updated
January 7, 2008
Record last verified: 2008-01