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| Sponsor: | Bispebjerg Hospital |
|---|---|
| Collaborators: |
University of Copenhagen Lundbeck Foundation Glostrup University Hospital, Copenhagen |
| Information provided by: | Bispebjerg Hospital |
| ClinicalTrials.gov Identifier: | NCT00206986 |
Purpose
We want to try to improve information processing in schizophrenic patients via pharmacological intervention. The hypothesis is that decreased noradrenergic activity will normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients with schizophrenia
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: clonidine |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia? |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | February 2006 |
A number of reports in literature provide evidence for, among others, an increased central noradrenergic activity in schizophrenia. In addition to this increased noradrenergic activity, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle reflex (PPI). In two separate initial studies in our laboratory, we found reduced sensory gating following administration of imipramine (a combined noradrenergic and serotonergic agonist) and desipramine (a highly specific noradrenergic agonist) to healthy volunteers. This provides evidence for a direct causal relation between the increased noradrenergic activity and the disturbed gating of sensory information, as both commonly found in patients with schizophrenia. Therefore, in a follow-up study, the effects of a noradrenergic antagonist will be investigated on the sensory gating of patients with schizophrenia. To further extend the data of our initial studies, the patients will additionally be tested for two psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will conform to a double blind, placebo controlled experiment, in which a single dose of 0.2 mg of clonidine will be added to the current medical treatment of 20 male patients with schizophrenia on two occasions, separated by at least a week, after which they are tested in a psychophysiological test battery.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients:
Controls:
Exclusion Criteria:
Patients:
Controls:
Contacts and Locations| Denmark | |
| Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | |
| Copenhagen NV, Denmark, DK-2400 | |
| Study Director: | Birte Glenthoj, MD, DMSc. | Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark |
More Information
| Study ID Numbers: | 363037-2, KF 11-261729 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 11, 2006 |
| ClinicalTrials.gov Identifier: | NCT00206986 History of Changes |
| Health Authority: | Denmark: National Board of Health |
|
Schizophrenia Information processing PPI P50 gating |
P300 mismatch negativity clonidine |
|
Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Clonidine Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists |
Pharmacologic Actions Schizophrenia Autonomic Agents Mental Disorders Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |