- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206960
Dopaminergic, Functional, Structural, and Cognitive Disturbances in First-episode Schizophrenia
Effects of Classical and Atypical Antipsychotics on Dopamine Receptor Binding of 123I-epidepride, Cognition, Startle Response and Extrapyramidal Side-effects in Drug-naive First-episode Schizophrenic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
31 neuroleptic-naive schizophrenic patients and 25 matched controls were recruited from the greater Copenhagen area. The patients were randomized to treatment with either low doses of the typical antipsychotic compound, zuclopenthixol, or the atypical drug, risperidone. Patients and controls were examined at base-line and patients were re-examined after 3 months of treatment.The study has resulted in two finish Ph.D. theses (Torben Mackeprang and Birgitte Fagerlund).
The data has in part been published in:
Mackeprang T, Tjelle Kristiansen K, Glenthoj B. Prepulse inhibition of the startle response in drug-naïve, first-episode schizophrenic patients before and after 3 months of treatment with a typical or an atypical antipsychotic drug. Biological Psychiatry 2002; 52(9): 863-873.
and
Fagerlund B, Mackeprang T, Gade A, Hemmingsen R, Glenthoj BY. Effects of Low-Dose Risperidone and Low-Dose Zuclopenthixol on Cognitive Functions in First-Episode Drug-Naïve Schizophrenic Patients. CNS Spectr. 2004; 9: 364-74.
and
Glenthoj BY, Mackeprang T, Svarer C, Rasmussen H, Pinborg L, Friberg L, Baaré W, Hemmingsen R, Videbæk C. Frontal dopamine D2/3 receptor binding in drug-naïve first-episode schizophrenic patients correlates with positive psychotic symptoms and gender. Biological Psychiatry 2006; in press. Mar 30; [Epub ahead of print]. PMID: 16784819 [PubMed - as supplied by publisher].
We are at present conducting a five-year follow-up study of the same cohort of patients and controls and plan a ten-year follow-up as well. The follow-up studies focus on brain structure (MRI), brain function, information processing, and psychopathology. We will correlate changes in structure and function to treatment, but no interventions (pharmacological or otherwise) are planned.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, DK-2100
- Neurobiology Research Unit, University of Copenhagen, Rigshospitalet
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Copenhagen NV, Denmark, DK-2400
- Dept. of Nuclear Medicine, University of Copenhagen, Bispebjerg Hospital
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Copenhagen NV, Denmark, DK-2400
- University of Copenhagen, Dept. F, Bispebjerg Hospital
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Copenhagen NV, Denmark, DK-2400
- University of Copenhagen, Dept. of Psychiatry E, Bispebjerg Hospital
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Glostrup, Denmark, DK-2600
- Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, 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:
- For patients: Clinical diagnosis of schizophrenia.
- The controls were matched to the patients.
Exclusion Criteria:
- Patients: Previous antipsychotic treatment, patients who were compulsorily hospitalised or deemed in acute need of medication, mental retardation
- Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives, drug abuse, mental retardation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
Patients will be administered risperidone orally in doses between 1-6 mg/day, depending on an effective reduction of symptoms
Other Names:
|
Active Comparator: 1
|
Patients will be administered zuclopenthixol orally in doses between 4 -24 mg/day, depending on an effective reduction of symptoms
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All examinations are done at baseline (patients and controls). In the patient group, they are repeated after 3 months of treatment
Time Frame: prospective
|
prospective
|
PANSS
Time Frame: prospective
|
prospective
|
SANS
Time Frame: prospective
|
prospective
|
SAPS
Time Frame: prospective
|
prospective
|
MRI
Time Frame: prospective
|
prospective
|
fMRI
Time Frame: prospective
|
prospective
|
startle response
Time Frame: prospective
|
prospective
|
PrePulse Inhibition of the startle response (PPI)
Time Frame: prospective
|
prospective
|
Cognition
Time Frame: prospective
|
prospective
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The cognitive test battery comprised tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB) as well as paper-and-pencil cognitive tests.
Time Frame: prospective
|
prospective
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Birte Glenthoj, MD, DMSc, University of Copenhagen, Psychiatric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark
Publications and helpful links
General Publications
- Mackeprang T, Kristiansen KT, Glenthoj BY. Effects of antipsychotics on prepulse inhibition of the startle response in drug-naive schizophrenic patients. Biol Psychiatry. 2002 Nov 1;52(9):863-73. doi: 10.1016/s0006-3223(02)01409-9.
- Fagerlund B, Mackeprang T, Gade A, Glenthoj BY. Effects of low-dose risperidone and low-dose zuclopenthixol on cognitive functions in first-episode drug-naive schizophrenic patients. CNS Spectr. 2004 May;9(5):364-74. doi: 10.1017/s1092852900009354.
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
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
- Clopenthixol
Other Study ID Numbers
- 363002
- KF 01-078/97
- KF 01-012/98
- KF 11-057/99
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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