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

NCT00206986 | Completed

• 2 other identifiers: 363037-2KF 11-261729
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (6)

• The following psychophysiological measures:

  prospective

• Prepulse Inhibition og the Startle Response (PPI)

  Once, 3.5 hrs after intake of capsule

• P50 suppression

  Once, 3.5 hrs after intake of capsule

• P300 Event Related Potential

  Once, 3.5 hrs after intake of capsule

• Mismatch negativity

  Once, 3.5 hrs after intake of capsule

• PANSS

  5 times hourly after intake of capsule

Study Arms (2)

1

EXPERIMENTAL

Drug: clonidine

2

EXPERIMENTAL

Drug: clonidine

Interventions

clonidine 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

Also known as: Catapressan

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birte Glenthoj: lead
• University of Copenhagen: collaborator
• Lundbeck Foundation: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

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

Copenhagen NV, DK-2400, Denmark

Location

Related Links

• Center for Neuropsychiatric Schizophrenia Research (CNSR)

MeSH Terms

Conditions

Schizophrenia

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Birte Glenthoj, MD, DMSc.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

DK (1)