Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?

December 19, 2013 updated by: Birte Glenthoj
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, DK-2400
        • Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Catapressan
Drug: clonidine
0.15 mg of clonidine will be administered to 20 healthy male volunteers
Other Names:
  • Catapressan
Experimental: 2
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 Names:
  • Catapressan
Drug: clonidine
0.15 mg of clonidine will be administered to 20 healthy male volunteers
Other Names:
  • Catapressan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The following psychophysiological measures:
Time Frame: prospective
prospective
Prepulse Inhibition og the Startle Response (PPI)
Time Frame: Once, 3.5 hrs after intake of capsule
Once, 3.5 hrs after intake of capsule
P50 suppression
Time Frame: Once, 3.5 hrs after intake of capsule
Once, 3.5 hrs after intake of capsule
P300 Event Related Potential
Time Frame: Once, 3.5 hrs after intake of capsule
Once, 3.5 hrs after intake of capsule
Mismatch negativity
Time Frame: Once, 3.5 hrs after intake of capsule
Once, 3.5 hrs after intake of capsule
PANSS
Time Frame: 5 times hourly after intake of capsule
5 times hourly after intake of capsule

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birte Glenthoj

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 363037-2
  • KF 11-261729

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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