In-Patient Study In Schizophrenic Patients

Phase 1CompletedNCT00197093

GlaxoSmithKline60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

SB773812DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.

Secondary Outcomes

Assessment of (1) changes in testing scores on a range of psychiatric assessments (PANSS, BPRS. CGI) (2) psychometric performance and (3)body weight/ girth measurement /glucose and lipd measurement, each as a function of duration of dosing.

Data from ClinicalTrials.gov

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