A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Pa… (NCT00077727) | Clinical Trial Compass
CompletedPhase 3
A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.
107 participantsStarted 2003-03
Plain-language summary
The purpose of this study is to determine if adding extended-release galantamine hydrobromide, compared with adding placebo, to current atypical antipsychotic therapy is well tolerated and effective in improving cognitive impairment in patients with schizophrenia.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Diagnosis of schizophrenia present for at least 1 year, and has not returned to his/her level of functioning before the disease, with a Brief Psychiatric Rating Scale score of 30 to 60 (inclusive), and cognitive impairment as determined by scores from neuropsychological tests and subtests
* Nicotine user with a minimum intake equivalent to 5 cigarettes per day
* On a stable dose of allowed atypical antipsychotic medication (risperidone \[either oral or CONSTA\], olanzapine, quetiapine, ziprasidone, or aripiprazole) alone or in combination, for at least 30 days before screening, and deemed able to continue on the same dose
* Women patients must be postmenopausal, surgically sterile, or using appropriate contraception before entry and throughout the study, and have a negative pregnancy test at screening
* Able to read, write, and understand English, and has no limitations in communication skills that would prevent him/her from completing the cognitive tests used in this study.
Exclusion Criteria:
* Previously enrolled in a galantamine hydrobromide study
* Any clinically significant uncontrolled medical illness (such as peptic ulcer disease
* urinary tract obstruction
* or neurologic, cardiac, hepatic, renal, metabolic, or endocrine disturbances)
* History of severe asthma
* Any history of epilepsy or convulsions, except for febrile convulsions during childhood
* History of cancer within the past year, except for treated basal cell carcinoma, or any hist…
What they're measuring
1
The key exploratory efficacy end points are the change from baseline to Week 8 in total PANSS score, total BACS score, and CGI global improvement and severity of illness scores.
Trial details
NCT IDNCT00077727
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.