The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia

NCT00206947

Last updated date
Study Location
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Dept. F, Bispebjerg Hospital
Copenhagen NV, , DK-2400, Denmark
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

SchizophreniaThe CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia
NCT00206947
  1. Copenhagen NV,
  2. Copenhagen,
  3. Glostrup,
  4. Hvidovre,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaStudy Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
NCT00892021
  1. Rockville, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaLarge Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)
NCT00418171
  1. San Bernardino, California
  2. Aiea, Hawaii
  3. Schaumburg, Illinois
  4. Grants Pass, Oregon
  5. Whitehall, West Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
NCT01939548
  1. Birmingham, Alabama
  2. Little Rock, Arkansas
  3. Cerritos, California
  4. Culver City, California
  5. Escondido, California
  6. Garden Grove, California
  7. Oakland, California
  8. Oceanside, California
  9. Orange, California
  10. Riverside, California
  11. San Diego, California
  12. San Diego, California
  13. Torrance, California
  14. Hartford, Connecticut
  15. Hartford, Connecticut
  16. New Haven, Connecticut
  17. Washington, District of Columbia
  18. Bradenton, Florida
  19. Brandenton, Florida
  20. Lauderhill, Florida
  21. Sanford, Florida
  22. Atlanta, Georgia
  23. Hoffman Estates, Illinois
  24. Hoffman Estates, Illinois
  25. Schaumburg, Illinois
  26. Lake Charles, Louisiana
  27. Shreveport, Louisiana
  28. Rockville, Maryland
  29. O'Fallon, Missouri
  30. St. Louis, Missouri
  31. Las Vegas, Nevada
  32. Jamaica, New York
  33. New York, New York
  34. Ward's Island, New York
  35. Dayton, Ohio
  36. Oklahoma City, Oklahoma
  37. Memphis, Tennessee
  38. Austin, Texas
  39. Austin, Texas
  40. Dallas, Texas
  41. Dallas, Texas
  42. DeSoto, Texas
  43. Salt Lake City, Utah
  44. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia
Official Title  ICMJE PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS: The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment
    Other Name: Zeldox
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: donepezil (5-10 mg/day)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 20, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00206947
Other Study ID Numbers  ICMJE 363051
KF 02-033/02
DMA 2612-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Birte Glenthoj, University of Copenhagen
Study Sponsor  ICMJE Birte Glenthoj
Collaborators  ICMJE
  • Rigshospitalet, Denmark
  • Glostrup University Hospital, Copenhagen
  • Pfizer
Investigators  ICMJE
Study Director:Birte Glenthoj, MD, DMSc.Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
PRS Account University of Copenhagen
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP