NCT00206947

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).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 schizophrenia

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 20, 2011

Status Verified

July 1, 2008

Enrollment Period

2.1 years

First QC Date

September 11, 2005

Last Update Submit

September 19, 2011

Conditions

Schizophrenia

Keywords

Cognitive deficitsCholinergic AugmentationSchizophrenia

Outcome Measures

Primary Outcomes (4)

  • PANSS (Positive and Negative Symptom Scale)

    baseline and after treatment

  • the CGI (Clinical Global Impression scale)

    baseline and after treatment

  • the ESRS (Extrapyramidal Symptom Rating Scale)

    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.

    baseline and after treatment

Secondary Outcomes (2)

  • MRI

    baseline and after treatment

  • fMRI

    baseline and after treatment

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: donepezil (5-10 mg/day)

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

donepezil (5-10 mg/day)DRUG

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

Also known as: Aricept, Zeldox
1
PlaceboDRUG

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

Also known as: Zeldox
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept. of Psychiatry O, Rigshospitalet, Blegdamsvej 9

Copenhagen, DK-2100, Denmark

Location

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

Copenhagen NV, DK-2400, Denmark

Location

Psychiatric Center, Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Related Links

MeSH Terms

Conditions

SchizophreniaCognition Disorders

Interventions

Donepezilziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Birte Glenthoj, MD, DMSc.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 21, 2005

Study Start

December 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

September 20, 2011

Record last verified: 2008-07

Locations

DK(4)