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Safety and Efficacy of RGH-188 in the Acute Exacerbation of 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: NCT00694707
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : March 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: RGH-188 Drug: Risperidone Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Study Start Date : June 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. PANSS total score [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Clinical Global Impression - Severity [ Time Frame: Week 6 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00694707


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

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
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents