Last updated: 07/14/2020 13:40:04
SB-773812 Administered In Adults With Schizophrenia
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi Centre, Double-Blind, Double-Dummy, Placebo-Controlled, Randomised, Adaptive, Dose-Range Study To Evaluate the Safety and Efficacy of SB-773812 Administered Once Daily for 12 Weeks in Adults With Schizophrenia
Trial description: This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in Part A. An interim analysis will be conducted to assess the efficacy and safety of the SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of SB-773812 will be added to the randomization for Part B.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
total score for each SB-773812 dose versus placebo at Week 6.
Timeframe: 12 Weeks
Secondary outcomes:
Evaluate safety of SB-773812 versus placebo and compared to olanzapine using PANNS scores -Measure the preliminary pharmacokinetic/pharmacodynamic relationships for SB-773812 -Assessment of movement disorders and cognitive functioning
Timeframe: 12 Weeks
Interventions:
Enrollment:
338
Primary completion date:
2007-03-08
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 2005 to August 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Meets the diagnostic criteria for schizophrenia as defined in DSM-IV.
- Subjects with a history of epilepsy or other seizure disorder, first episode of schizophrenia or other psychotic disorders (e.g. residual type schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, etc.)
- Bipolar disorder, a history of substance dependence, or a medical or psychiatric disorder that would interfere with the accurate assessment of safety or efficacy are not eligible.
Inclusion and exclusion criteria
Inclusion criteria:
- Meets the diagnostic criteria for schizophrenia as defined in DSM-IV. -PANSS total score of at least 70 at Screen and Baseline and a minimum score of 4 (moderate) on at least 2 of the following: conceptual disorganization (P2) hallucinatory behaviour (P3) suspiciousness (P6) or unusual thought content (G9) at the Screen and Baseline visits
Exclusion criteria:
- Subjects with a history of epilepsy or other seizure disorder, first episode of schizophrenia or other psychotic disorders (e.g. residual type schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, etc.)
- Bipolar disorder, a history of substance dependence, or a medical or psychiatric disorder that would interfere with the accurate assessment of safety or efficacy are not eligible.
Trial location(s)
Showing 1 - 6 of 42 Results
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2007-03-08
Actual study completion date
2007-03-08
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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