The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia

NCT ID: NCT00206947

Last Updated: 2011-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2005-01-31

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 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

donepezil (5-10 mg/day)

Intervention Type: DRUG

Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment

Interventions

donepezil (5-10 mg/day)

Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment

Intervention Type: DRUG

Placebo

Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment

Intervention Type: DRUG

Other Intervention Names

Aricept, Zeldox; Zeldox

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Birte Glenthoj

OTHER

Sponsor Role: lead

Responsible Party

Birte Glenthoj

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Birte Glenthoj, MD, DMSc.

Role: STUDY_DIRECTOR

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

Locations

Dept. of Psychiatry O, Rigshospitalet, Blegdamsvej 9

Copenhagen, , Denmark

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Dept. F, Bispebjerg Hospital

Copenhagen NV, , Denmark

Psychiatric Center, Glostrup

Glostrup Municipality, , Denmark

Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital

Hvidovre, , Denmark

Countries

Denmark

Related Links

http://www.cnsr.dk

Center for Neuropsychiatric Schizophrenia Research (CNSR)

Other Identifiers

KF 02-033/02

Identifier Type: -

Identifier Source: secondary_id

DMA 2612-2013

Identifier Type: -

Identifier Source: secondary_id

363051

Identifier Type: -

Identifier Source: org_study_id