The Effect of Imipramine on Early Information Processing - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

September 11, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

PrePulse Inhibition of the startle response
P50 ERP gating

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00206999 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effect of Imipramine on Early Information Processing

Official Title ^ICMJE

Early Information Processing in Healthy Controls: Studies on the Relation Between Two Different Paradigms (PPI and P50ERP) and Effects of Pharmacological Interventions

Brief Summary

We wanted to compare the relation of two different psychophysiological paradigms (PrePulse Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor, imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not correlate with each other at baseline. The secondary hypothesis was that increased noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Healthy Volunters

Intervention ^ICMJE

Drug: imipramine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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. Positive urine screening for amphetamine, cocaine, cannabis, or esctacy.

Gender

Male

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00206999

Responsible Party

Study ID Numbers ^ICMJE

363052-2, KF 01-305/99, KF 11-061/03, KF 11-068/03, KF 11-096/04

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

University of Copenhagen
Glostrup University Hospital,Copenhagen
The Danish Medical Research Council
Lundbeck Foundation

Investigators ^ICMJE

Study Director:

Birte Glenthoj, MD, DMSc.

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

Information Provided By

Bispebjerg Hospital

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP