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

NCT ID: NCT00206986

Last Updated: 2013-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Information processing; PPI; P50 gating; P300; mismatch negativity; clonidine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

clonidine

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

clonidine

Intervention Type: DRUG

0.15 mg of clonidine will be administered to 20 healthy male volunteers

Interventions

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

Intervention Type: DRUG

clonidine

0.15 mg of clonidine will be administered to 20 healthy male volunteers

Intervention Type: DRUG

Other Intervention Names

Catapressan; Catapressan

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Lundbeck Foundation

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

Birte Glenthoj

OTHER

Sponsor Role: lead

Responsible Party

Birte Glenthoj

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Birte Glenthoj, MD, DMSc.

Role: STUDY_DIRECTOR

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychaitric Center Glostrup, Ndr. Ringvej, DK-2600 Glostrup, Denmark

Locations

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Copenhagen NV, , Denmark

Countries

Denmark

Related Links

http://www.cnsr.dk

Center for Neuropsychiatric Schizophrenia Research (CNSR)

Other Identifiers

KF 11-261729

Identifier Type: -

Identifier Source: secondary_id

363037-2

Identifier Type: -

Identifier Source: org_study_id