A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Antipsychotic Agents; Galantamine

Criteria

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 history of prolactin-dependent breast cancer