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Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00694707
First received: June 6, 2008
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

This is an study to evaluate the safety, efficacy, and tolerability of RGH-188 relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Placebo
Drug: RGH-188
Drug: Risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • PANSS total score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Severity [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 732
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo, oral administration, once daily dosing for 6 weeks
Drug: Placebo
Placebo oral administration once daily for 6 weeks
Experimental: 2
RGH-188 low dose, oral administration, once daily dosing for 6 weeks
Drug: RGH-188
RGH-188 low dose once daily for 6 weeks
Experimental: 3
RGH-188 medium dose, oral administration, once daily dosing for 6 weeks
Drug: RGH-188
RGH-188 medium dose once daily for six weeks
Experimental: 4
RGH-188 high dose, oral administration, once daily dosing for 6 weeks
Drug: RGH-188
RGH-188 high dose oral administration once daily for six weeks
Active Comparator: 5
Active comparator, oral administration, once daily dosing for 6 weeks
Drug: Risperidone
Risperidone oral administration once daily for six weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 to 60 years of age
  • meeting DSM-IV criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type) based on the SCID
  • having a total PANSS score greater than or equal to 80 and less than or equal to 120
  • Patients with a schizophrenia diagnosis for a minimum of 1 year.

Exclusion Criteria:

  • Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values.
  • Patients experiencing first episode of psychosis.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694707

  Show 65 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Suresh Durgam, MD Forest Laboratories
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00694707     History of Changes
Obsolete Identifiers: NCT00892528
Other Study ID Numbers: RGH-MD-16
Study First Received: June 6, 2008
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
India: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Malaysia: Ministry of Health
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014