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Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RGH-188

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

For information regarding investigative sites, contact Forest Professional Affairs

Outcomes

Primary Outcome Measures

PANSS Total Score

Secondary Outcome Measures

CGI-S

Full Information

NCT ID

NCT00404573

First Posted

November 27, 2006

Last Updated

January 3, 2008

Sponsor

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00404573

Brief Title

Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

Official Title

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Forest Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

375 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

RGH-188

Primary Outcome Measure Information:

Title

PANSS Total Score

Secondary Outcome Measure Information:

Title

CGI-S

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

For information regarding investigative sites, contact Forest Professional Affairs

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63045

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34091867

Citation

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.

Results Reference

derived

PubMed Identifier

33854317

Citation

Barabassy 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. Erratum In: Neuropsychiatr Dis Treat. 2021 May 17;17:1481.

Results Reference

derived

PubMed Identifier

28692485

Citation

Earley 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.

Results Reference

derived

Learn more about this trial

Study Evaluating RGH-188 in the Treatment of Patients With Schizophrenia

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