Last updated: 11/04/2018 04:12:22
In-Patient Study In Schizophrenic Patients
GSK study ID
773812/003
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
60
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Schizophrenia
Product
SB773812
Collaborators
Not applicable
Study date(s)
September 2004 to August 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 Years
Accepts healthy volunteers
no
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-08-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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