In-Patient Study In Schizophrenic Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197093
First received: September 13, 2005
Last updated: May 15, 2009
Last verified: May 2009
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: SB773812 |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | A Placebo Controlled, Double-Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Ascending Multiple Oral Doses of SB-773812 in Male and Female Schizophrenic Patients for up to 28 Days |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Safety and Tolerability of 773812 during 28 days of dosing. Pharmacokinetics of 773812 after repeat dosing.
Secondary Outcome Measures:
- 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.
Estimated Enrollment: | 60 |
Study Start Date: | September 2004 |
Intervention Details:
-
Drug: SB773812
Other Name: SB773812
Eligibility
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00197093 History of Changes |
Other Study ID Numbers: | 773812/003 |
Study First Received: | September 13, 2005 |
Last Updated: | May 15, 2009 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
Schizophrenia safety tolerability pharmacokinetics |
Additional relevant MeSH terms:
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on October 16, 2012