The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS: The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology|
- PANSS (Positive and Negative Symptom Scale) [ Time Frame: baseline and after treatment ] [ Designated as safety issue: No ]
- the CGI (Clinical Global Impression scale) [ Time Frame: baseline and after treatment ] [ Designated as safety issue: No ]
- the ESRS (Extrapyramidal Symptom Rating Scale) [ Time Frame: baseline and after treatment ] [ Designated as safety issue: No ]
- Cognitive functions: A comprehensive test battery focuses on central cognitive deficits in schizophrenia: i.e. memory functions, attention, executive functions, reaction time, as well as pre-morbid and current intelligence. [ Time Frame: baseline and after treatment ] [ Designated as safety issue: No ]
- MRI [ Time Frame: baseline and after treatment ] [ Designated as safety issue: No ]
- fMRI [ Time Frame: baseline and after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2002|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Drug: donepezil (5-10 mg/day)
Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment
Other Name: Aricept, Zeldox
|Placebo Comparator: 2||
Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment
Other Name: Zeldox
The purpose of the study was to examine the effects of cholinergic augmentation of atypical antipsychotic medication on:
- Cognitive deficits
- Sensorimotor gating
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 Hospital,Rigshospitalet, 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.
|Dept. of Psychiatry O, Rigshospitalet, Blegdamsvej 9|
|Copenhagen, Denmark, DK-2100|
|Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Dept. F, Bispebjerg Hospital|
|Copenhagen NV, Denmark, DK-2400|
|Psychiatric Center, Glostrup|
|Glostrup, Denmark, DK-2600|
|Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital|
|Hvidovre, Denmark, DK-2650|
|Study Director:||Birte Glenthoj, MD, DMSc.||Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark|