Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077727
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2004-02-11
Brief Title:
A Study of the Effectiveness and Safety of Galantamine Hydrobromide on Cognitive Impairment in Patients With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Study of Galantamine HBr as an Adjunctive Treatment to Atypical Antipsychotic Medications in Outpatients With Schizophrenia and Associated Cognitive Deficits
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Galantamine acts on acetylcholinesterase and has been shown to effectively treat cognitive symptoms in patients with Alzheimers disease Previous cellular research of nicotinic receptors has shown promising results and it is theorized that the nicotinic system of patients with schizophrenia may be abnormal and may play an important role in the cognitive symptoms associated with schizophrenia It is also postulated that galantamine may improve neuropsychiatric symptoms such as hallucinations delusions and apathy in patients with Alzheimers disease Atypical antipsychotic medications are effective treatment for schizophrenia patients but some symptoms remain Therefore galantamine may be a useful cotreatment for schizophrenia patients on atypical antipsychotic treatment This is a pilot dose-ranging randomized patients are assigned different treatments based on chance double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage placebo-controlled multicenter study that examines the effects of taking extended-release galantamine hydrobromide 16 or 24 mg once daily or placebo on the effectiveness in reducing symptoms of schizophrenia patients who are already taking an atypical antipsychotic medication The safety of combined treatment is also examined Measures of effectiveness include the Positive and Negative Syndrome Scale PANSS to measure neuropsychiatric symptoms of schizophrenia the Clinical Global Impression CGI scale to measure change over the course of the study the Brief Assessment of Cognition in Schizophrenia BACS for verbal memory and learning working memory motor function attention verbal fluency and executive functioning the Continuous Performance Test CPT for sustained attention and distractability reaction time test RTT and finger tapping test FTT for psychomotor speed Lexical and Semantic Fluency Test LSFT for language skills As schizophrenia patients are a population with high nicotine use and galantamine may act on nicotine receptors blood levels of nicotine are also measured as varying nicotine levels could alter the effects of galantamine The null hypothesis that there is no difference between the 2 groups galantamine cotreatment and placebo will be tested for each of the efficacy measurements total PANSS BACS and CGI scores at Week 8 Measures of safety include physical examinations electrocardiograms ECGs clinical laboratory tests measurement of plasma prolactin concentrations pregnancy test for women and incidence of adverse events Adverse events that might be related to the medications are also monitored using the Simpson-Angus Extrapyramidal Side Effects Scale SAS the Barnes Akathisia Rating Scale BARS and the Abnormal Involuntary Movement Scale AIMS Extended-release galantamine hydrobromide or matching placebo capsules for once-daily dosing Patients take 8 milligrams mg per day during Week 1 16 mg per day during Week 2 and 16 mg or 24 mg per day depending on randomization during Weeks 3 to 8 Treatment groups are placebo capsule 16 mg capsule 24 mg capsule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None