A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia.
A Study of Galantamine HBr as an Adjunctive Treatment to Atypical Antipsychotic Medications in Outpatients With Schizophrenia and Associated Cognitive Deficits.
1 other identifier
interventional
107
0 countries
N/A
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 in improving cognitive impairment in patients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Mar 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 11, 2004
CompletedFirst Posted
Study publicly available on registry
February 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedMay 24, 2011
April 1, 2010
February 11, 2004
May 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Secondary Outcomes (1)
Additional efficacy assessments included subscore analyses for LSFT, CPT, RTT and FTT.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 11, 2004
First Posted
February 16, 2004
Study Start
March 1, 2003
Study Completion
February 1, 2005
Last Updated
May 24, 2011
Record last verified: 2010-04