Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320736
Status:
COMPLETED
Last Update Posted:
2009-05-19
First Post:
2006-04-28
Brief Title:
Galantamine for Cognition in People With Schizophrenia
Sponsor:
North Suffolk Mental Health Association
Organization:
North Suffolk Mental Health Association
Study Overview
Official Title:
Effect of Nicotine Agonist Galantamine Added to High Potency Medications for Cognitive Function in Patients With Schizophrenia and Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2009-05
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:
This study is a double-blind placebo-controlled trial of the nicotinic receptor agonist galantamine for the improvement of memory and attention in people with schizophrenia and schizoaffective disorder Twenty subjects on a stable dose of antipsychotic medications receive galantamine or identical placebo tablets for 8 weeks Adverse events are screened for every week Tests of memory attention and reward responsivity are performed at baseline and afer 8 weeks on medication Clinical scales rating psychiatric symptoms are performed at the beginning middle and end of the trial
Detailed Description:
Background
Galantamine is a novel acetylcholinesterase inhibitor that is also a positive allosteric modulator of nicotinic acetylcholine receptors Galantamine has been shown to increase conductivity of nicotinic receptors through a binding site that is discreet from the acetylcholine receptor There is minimal risk of overstimulation with positive allosteric modulators as they do not produce receptor depolarization but potentiate submaximal acetylcholine induced depolarization Our hypothesis is that allosteric modulation of nicotinic acetylcholine receptors is a potentially important treatment strategy in schizophrenia We propose a trial of galantamine augmentation of antipsychotic medication in the treatment of schizophrenia to test the following hypotheses
Hypotheses
1 Galantamine augmentation of antipsychotic treatment will be associated with improvement from baseline in performance on the cognitive battery Stroop Cornblatt CPT-IP CDR Battery letter number span Grooved peg board Tower of London and Signal Detection Task
2 Galantamine augmentation of high potency antipsychotic treatment will be well tolerated and associated with improvement from baseline in negative symptoms SANS depressive symptoms CDSS and impulsivity PANSS aggression item
Study Design
Twenty adult subjects aged 18-60 will be randomized according to a double blind parallel group design to receive galantamine or identical placebo for 8 weeks Subjects will begin with a dose of up to 8 mg twice per day for the first four weeks then up to 16 mg twice per day for the next four weeks Visits will be weekly to monitor medication compliance and medication side effects Prior to beginning treatment subjects will undergo a 15 hour training session to familiarize themselves with the CDR battery portion of the cognitive battery Subjects will then be evaluated for symptoms of psychosis depression anxiety smoking behavior and medication side effects with standard clinical rating scales that include the Schedule for Assessment of Negative Symptoms SANS Positive and Negative Symptom Scale PANSS Brief Psychiatric Rating Scale BPRS Calgary Depression Scale for Schizophrenia CDSS Abnormal Involuntary Movement Scale AIMS Simpson Angus Scale and Barnes Akathisia Scale Fagerstrom Test of Nicotine Dependence carbon monoxide measurement and smoking self report Subjects who meet criteria for current depression or who have suicidal ideation will be excluded Clinical rating scales will be performed at baseline and monthly Tests of visual and spatial working memory attention motor skills inhibition and motivation will be performed at baseline and at 8 weeks The cognitive battery will include tests of response inhibition the 3-card Stroop attention Cornblatt continuous performance test identical pairs CPT-IP and CDR Battery verbal memory CDR Battery working memory letter-number span non-verbal memory CDR Battery psychomotor ability grooved peg board task executive functioning Tower of London and motivation for reward signal detection task Blood will be drawn for antipsychotic levels galantamine levels and measurement of nicotinic receptor number at baseline and 8 weeks Adverse events will be documented at each visit using an Adverse Events Tracking log At baseline and week 8 carbon monoxide CO measurements will be used with self report to verify number of cigarettes smoked per day
Galantamine is a novel acetylcholinesterase inhibitor that is also a positive allosteric modulator of nicotinic acetylcholine receptors Galantamine has been shown to increase conductivity of nicotinic receptors through a binding site that is discreet from the acetylcholine receptor There is minimal risk of overstimulation with positive allosteric modulators as they do not produce receptor depolarization but potentiate submaximal acetylcholine induced depolarization Our hypothesis is that allosteric modulation of nicotinic acetylcholine receptors is a potentially important treatment strategy in schizophrenia We propose a trial of galantamine augmentation of antipsychotic medication in the treatment of schizophrenia to test the following hypotheses
Hypotheses
1 Galantamine augmentation of antipsychotic treatment will be associated with improvement from baseline in performance on the cognitive battery Stroop Cornblatt CPT-IP CDR Battery letter number span Grooved peg board Tower of London and Signal Detection Task
2 Galantamine augmentation of high potency antipsychotic treatment will be well tolerated and associated with improvement from baseline in negative symptoms SANS depressive symptoms CDSS and impulsivity PANSS aggression item
Study Design
Twenty adult subjects aged 18-60 will be randomized according to a double blind parallel group design to receive galantamine or identical placebo for 8 weeks Subjects will begin with a dose of up to 8 mg twice per day for the first four weeks then up to 16 mg twice per day for the next four weeks Visits will be weekly to monitor medication compliance and medication side effects Prior to beginning treatment subjects will undergo a 15 hour training session to familiarize themselves with the CDR battery portion of the cognitive battery Subjects will then be evaluated for symptoms of psychosis depression anxiety smoking behavior and medication side effects with standard clinical rating scales that include the Schedule for Assessment of Negative Symptoms SANS Positive and Negative Symptom Scale PANSS Brief Psychiatric Rating Scale BPRS Calgary Depression Scale for Schizophrenia CDSS Abnormal Involuntary Movement Scale AIMS Simpson Angus Scale and Barnes Akathisia Scale Fagerstrom Test of Nicotine Dependence carbon monoxide measurement and smoking self report Subjects who meet criteria for current depression or who have suicidal ideation will be excluded Clinical rating scales will be performed at baseline and monthly Tests of visual and spatial working memory attention motor skills inhibition and motivation will be performed at baseline and at 8 weeks The cognitive battery will include tests of response inhibition the 3-card Stroop attention Cornblatt continuous performance test identical pairs CPT-IP and CDR Battery verbal memory CDR Battery working memory letter-number span non-verbal memory CDR Battery psychomotor ability grooved peg board task executive functioning Tower of London and motivation for reward signal detection task Blood will be drawn for antipsychotic levels galantamine levels and measurement of nicotinic receptor number at baseline and 8 weeks Adverse events will be documented at each visit using an Adverse Events Tracking log At baseline and week 8 carbon monoxide CO measurements will be used with self report to verify number of cigarettes smoked per day
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