Status:
COMPLETED
A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief 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 i...
Detailed Description
Galantamine acts on acetylcholinesterase, and has been shown to effectively treat cognitive symptoms in patients with Alzheimer's disease. Previous cellular research of nicotinic receptors has shown p...
Eligibility Criteria
Inclusion
- 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
- 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 history of prolactin-dependent breast cancer
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00077727
Start Date
March 1 2003
End Date
February 1 2005
Last Update
May 24 2011
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