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Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?
This study is ongoing, but not recruiting participants.
First Received: September 12, 2005   Last Updated: September 11, 2006   History of Changes
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?

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • The following psychophysiological measures:
  • Prepulse Inhibition og the Startle Response (PPI)
  • P50 suppression
  • P300 Event Related Potentials
  • Mismatch negativity
  • PANSS

Estimated Enrollment: 40
Study Start Date: May 2005
Estimated Study Completion Date: February 2006
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Patients:

    • Male subjects
    • Meeting the DSM-IV diagnosis of schizophrenia
  • Controls:

    • Male subjects
    • Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist
    • Non smokers

Exclusion Criteria:

  • Patients:

    • A P50 suppression or PPI score falling within a range of 10 percent above or below the mean score of the healthy control group
  • Controls:

    • Current use of any medication
    • Any subject who has received any investigational medication within 30 days prior to the start of this study
    • History of neurologic illness
    • History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
    • History of alcohol and drug abuse.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206986

Locations
Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Copenhagen NV, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
University of Copenhagen
Lundbeck Foundation
Glostrup University Hospital, Copenhagen
Investigators
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

Additional Information:
No publications provided

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

Keywords provided by Bispebjerg Hospital:
Schizophrenia
Information processing
PPI
P50 gating
P300
mismatch negativity
clonidine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010