- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206947
The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia
PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS: The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Copenhagen, Denmark, DK-2100
- Dept. of Psychiatry O, Rigshospitalet, Blegdamsvej 9
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Copenhagen NV, Denmark, DK-2400
- Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Dept. F, Bispebjerg Hospital
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Glostrup, Denmark, DK-2600
- Psychiatric Center, Glostrup
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Hvidovre, Denmark, DK-2650
- Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment
Other Names:
|
Active Comparator: 1
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Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PANSS (Positive and Negative Symptom Scale)
Time Frame: baseline and after treatment
|
baseline and after treatment
|
the CGI (Clinical Global Impression scale)
Time Frame: baseline and after treatment
|
baseline and after treatment
|
the ESRS (Extrapyramidal Symptom Rating Scale)
Time Frame: baseline and after treatment
|
baseline and after treatment
|
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
|
baseline and after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI
Time Frame: baseline and after treatment
|
baseline and after treatment
|
fMRI
Time Frame: baseline and after treatment
|
baseline and after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Birte Glenthoj, MD, DMSc., Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Cognitive Dysfunction
- Cognition Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Cholinergic Agents
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Nootropic Agents
- Cholinesterase Inhibitors
- Ziprasidone
- Donepezil
Other Study ID Numbers
- 363051
- KF 02-033/02
- DMA 2612-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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