In-Patient Study In Schizophrenic Patients

NCT ID: NCT00197093

Last Updated: 2009-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30

Brief Summary

This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days. Assessments include blood sampling to determine drug concentrations, psychiatric assessments while under treatment, and movement assessments to evaluate potential side effects.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

SB773812

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have schizophrenia that has been stable for at least three months.
• Willing to discontinue current anti-psychotic medications (under supervision) prior to the study.
• Willing to live at the study center for a total of 38 days and then return for three follow-up visits.

Exclusion Criteria

• Taking medications for conditions other than schizophrenia.
• History of alcohol or drug abuse within six months of the study, and their alcohol consumption must meet moderate guidelines.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

773812/003

Identifier Type: -

Identifier Source: org_study_id