|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Birte Glenthoj |
|---|---|
| Collaborators: |
University of Copenhagen Lundbeck Foundation Glostrup University Hospital, Copenhagen |
| Information provided by (Responsible Party): | Birte Glenthoj, University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00206986 |
Purpose
The investigators 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: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: clonidine
Either placebo or 25 ug, 50 uG 75 ug or 150 ug of clonidine will be added to the current medication of patients with schizophrenia, who are stable on their current medication
Other Name: Catapressan
|
| Experimental: 2 |
Drug: clonidine
0.15 mg of clonidine will be administered to 20 healthy male volunteers
Other Name: Catapressan
|
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 either four doses (0.25 ug, 50 ug, 75 ug or 150 ug)of clonidine or placebo will be added to the current medical treatment of 20 male patients with schizophrenia on five occasions, separated by at least a week, after which they are tested in the Copenhagen Psychophysiological Test Battery (CPTB).In order to test the effects of clonidine in healthy volunteers, 20 healthy males will receive a fixed dose of 0.15 mg clonidine or placebo on two separate occasions separated by at least a week, after which they will be tested in the CPTB as well.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients:
Controls:
Exclusion Criteria:
Patients:
Controls:
Contacts and Locations| Contact: Bob Oranje, PhD | +45 43 23 34 31 | b.oranje@cnsr.dk |
| Denmark | |
| Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup | Recruiting |
| Copenhagen NV, Denmark, DK-2400 | |
| Contact: Bob Oranje, PhD +45 432 34638 b.oranje@cnsr.dk | |
| Principal Investigator: Bob Oranje, Ph.D. | |
| Sub-Investigator: Birte Glenthoj, MD, DMSc. | |
| 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
| Responsible Party: | Birte Glenthoj, Professor, University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00206986 History of Changes |
| Other Study ID Numbers: | 363037-2, KF 11-261729 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 19, 2011 |
| Health Authority: | Denmark: National Board of Health |
|
Schizophrenia Information processing PPI P50 gating |
P300 mismatch negativity clonidine |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |