Status:
TERMINATED
The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia
Lead Sponsor:
Birte Glenthoj
Collaborating Sponsors:
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 psychop...
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 obje...
Eligibility Criteria
Inclusion
- Patients: 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 Hospital, Psychiatric Center, Glostrup and Rigshospitalet. 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.
- Controls: Healthy men and women matched according to gender, age, and socio-economic status (determined by the level of education and income of parents).
Exclusion
- Patients: Patients hospitalized against their will. Patients with a serious medical illness or with laboratory abnormalities, where pharmacotherapy poses a substantial clinical risk; pregnant or lactating patients; patients with organic psychosis, a history of severe head trauma or convulsive disorders, or patients with mental retardation. Patients with significant alcohol- or drug dependence are excluded.
- Controls: Pregnant or lactating women; a history of severe head trauma; mental retardation; learning difficulties; a history of psychiatric illness or a familial predisposition to psychiatric illness (in first-degree relatives); significant alcohol- or drug dependence; episodic incidents of excessive alcohol consumption or drug abuse are not reasons for exclusion. Abuse is monitored by interviewing patients and by measuring the urine content for amphetamine, cannabinoles, opiates, and benzodiazepines. Concomitant use of benzodiazepines for agitation or insomnia (oxazepam up to 45 mg daily) is allowed when needed and when used conservatively during the trial. Use of anticholinergic compounds is not allowed.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00206947
Start Date
December 1 2002
End Date
January 1 2005
Last Update
September 20 2011
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. of Psychiatry O, Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark, DK-2100
2
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Dept. F, Bispebjerg Hospital
Copenhagen NV, Denmark, DK-2400
3
Psychiatric Center, Glostrup
Glostrup Municipality, Denmark, DK-2600
4
Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital
Hvidovre, Denmark, DK-2650