Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161044
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2005-09-08
Brief Title:
An Open-Label Investigation of the Adjuvant Therapeutic Effects of Galantamine in Patients With Chronic Schizophrenia and Persistent Deficit Symptoms
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
An Open-Label Investigation of the Adjuvant Therapeutic Effects of Galantamine in Patients With Chronic Schizophrenia and Persistent Deficit Symptoms
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if galantamine is an effective agent for the treatment of the cognitive abnormalities negative symptoms and or behavioral impairments seen in schizophrenia
Detailed Description:
In this exploratory investigation we propose to study the adjuvant therapeutic efficacy and safety of galantamine in 20 patients with chronic schizophrenia who are maintained on a stable regimen of antipsychotic medication for at least two weeks prior to enrollment see Table 1 for Selection Criteria Assessments of neuropsychological performance will be made prior to the start of galantamine therapy and at study endpoint Upon enrollment neuropsychological tests will be administered by the study neuropsychologist or a trained and supervised assessment technician in fixed order and according to standardized testing procedures The following tests will be administered 1 Repeatable Battery for the Assessment of Neuropsychological Status RBANS covering a verbal and visual episodic memory b verbal response generation and self-monitoring c auditory attention and working memory and d sustained attention and psychomotor speed and 2 Grooved Pegboard Test motor speed RBANS administration will be counterbalanced using Forms A and B across subjects and assessment points to prevent order effects Remaining assessments will be administered at baseline after galantamine titration and at weeks 4 and 8 of galantamine treatment Psychiatric symptoms and behavior will be assessed using the Brief Psychiatric Rating Scale BPRS the Scale for the Assessment of Negative Symptoms SANS the Montgomery-Asberg Depression Rating Scale MADRS the Neuropsychiatric Inventory NPI the Clinical Global Impression Scale CGI and the Apathy Evaluation Scale AES Trained research nurses psychologists and psychiatrists will administer the symptom behavior and functional scales with established inter-rater reliability In this study adverse effects will be monitored through self-reporting and observation Vital signs will be collected on a weekly basis Additionally motor and movement side effects will be rated by trained research nurses using the Extrapyramidal Symptom Rating Scale EPRS the Barnes Akathisia Scale BAS and the Abnormal Involuntary Movements Scale AIMS Following their initial neuropsychological assessment patients will enter a three week galantamine titration phase during which galantamine will be added to the stable regimen of antipsychotic medication according to the following titration schedule 8 mgday for the first week followed by 16 mgday in the second and 24 mgday in the third week Raskin et al 2000 At the end of this titration phase patients will be receiving the maximal allowable dose of galantamine ie 24 mgday or an optimal dose ie the highest tolerable dose devoid of significant side effects eg 16 mgday Moreover at the end of this titration phase patients will be administered the standard battery of rating instruments prior to entering an 8-week period of active treatment with the maximal or optimal adjuvant therapeutic dose of galantamine During the active treatment phase the standard battery of rating instruments will be administered at the end of the fourth and eighth week of active treatment Patients admitted to the 364A Unit at Perry Point will have their charts reviewed to see if they meet the inclusion criteria for the study After approval by the principal investigator the patient will be approached by a designated member of the research team for their interest in participating in the study
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