Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206947
Status:
TERMINATED
Last Update Posted:
2011-09-20
First Post:
2005-09-11
Brief Title:
The CAMPUS Project Cholinergic Augmentation of Cognitive Deficits in Schizophrenia
Sponsor:
Birte Glenthoj
Organization:
University of Copenhagen
Study Overview
Official Title:
PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology
Status:
TERMINATED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No more funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will specify and delineate the separate components of cognitive deficits and examine the effects of adjunctive cholinergic augmentation on these cognitive deficits as well as psychopathology in schizophrenic patients treated with an antipsychotic compound with no aberrant binding affinity for the cholinergic receptor system The hypothesis is that cholinergic augmentation using donepezil will improve cognitive deficits sensory gating deficits and psychopathology in schizophrenic patients treated with an atypical antipsychotic ziprasidone
Detailed Description:
The purpose of the study was to examine the effects of cholinergic augmentation of atypical antipsychotic medication on
Cognitive deficits
Sensorimotor gating
Psychopathology
The primary objective was to examine
The effects of donepezil compared to the effects of placebo on cognitive function sensorimotor gating and psychopathology in patients treated with an atypical antipsychotic ziprasidone
Secondary objectives are to examine
The effect of donepezil compared to the effects of placebo on cognitive function sensorimotor gating and psychopathology in patients treated with ziprasidone
Which specific areas of cognitive deficits benefit from cholinergic augmentation of atypical antipsychotic treatment
The interactions between cognitive deficits and psychopathology To what extent the effects of cholinergic augmentation on psychopathology sensorimotor gating and cognition are independent or correlated
Which specific brain areas are activated during cholinergic augmentation of treatment with an atypical antipsychotic drug ziprasidone
Participants Schizophrenic men and women between the ages 18 to 55 who meet the ICD-10 criteria for schizophrenia living in the catchment area of the psychiatric departments of Bispebjerg University HospitalRigshospitalet or Psychiatric Center Glostrup Patients can be either unmedicated or need to be switched from other antipsychotic medications due to side-effects or lack of effect on negative symptoms positive symptoms or cognitive function Patients can be enrolled in the study as inpatients or outpatients and changes in hospitalization status during the trial are allowed Patients were stabilized on antipsychotic medication ziprasidone before they were randomized to treatment with either donepezil or placebo
Cognitive deficits
Sensorimotor gating
Psychopathology
The primary objective was to examine
The effects of donepezil compared to the effects of placebo on cognitive function sensorimotor gating and psychopathology in patients treated with an atypical antipsychotic ziprasidone
Secondary objectives are to examine
The effect of donepezil compared to the effects of placebo on cognitive function sensorimotor gating and psychopathology in patients treated with ziprasidone
Which specific areas of cognitive deficits benefit from cholinergic augmentation of atypical antipsychotic treatment
The interactions between cognitive deficits and psychopathology To what extent the effects of cholinergic augmentation on psychopathology sensorimotor gating and cognition are independent or correlated
Which specific brain areas are activated during cholinergic augmentation of treatment with an atypical antipsychotic drug ziprasidone
Participants Schizophrenic men and women between the ages 18 to 55 who meet the ICD-10 criteria for schizophrenia living in the catchment area of the psychiatric departments of Bispebjerg University HospitalRigshospitalet or Psychiatric Center Glostrup Patients can be either unmedicated or need to be switched from other antipsychotic medications due to side-effects or lack of effect on negative symptoms positive symptoms or cognitive function Patients can be enrolled in the study as inpatients or outpatients and changes in hospitalization status during the trial are allowed Patients were stabilized on antipsychotic medication ziprasidone before they were randomized to treatment with either donepezil or placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMA 2612-2013 | None | None | None |
| KF 02-03302 | None | None | None |