The Effect of Imipramine on Early Information Processing

This study is ongoing, but not recruiting participants.

First Received: September 11, 2005 Last Updated: September 11, 2006 History of Changes

Sponsor:	Bispebjerg Hospital
Collaborators:	University of Copenhagen Glostrup University Hospital,Copenhagen The Danish Medical Research Council Lundbeck Foundation
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00206999

Purpose

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.

Condition	Intervention
Healthy Volunters	Drug: imipramine

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Early Information Processing in Healthy Controls: Studies on the Relation Between Two Different Paradigms (PPI and P50ERP) and Effects of Pharmacological Interventions

Resource links provided by NLM:

Drug Information available for: Imipramine Imipramine hydrochloride

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

PrePulse Inhibition of the startle response
P50 ERP gating

Estimated Enrollment:	20
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206999

Locations

Denmark
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup
Glostrup, Denmark, DK-2600

Sponsors and Collaborators

Bispebjerg Hospital

University of Copenhagen

Glostrup University Hospital,Copenhagen

The Danish Medical Research Council

Lundbeck Foundation

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:

Center for Neuropsychiatric Schizophrenia Research (CNSR) This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	363052-2, KF 01-305/99, KF 11-061/03, KF 11-068/03, KF 11-096/04
Study First Received:	September 11, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00206999 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:

Psychophysiology
PPI
P50 suppression
Imipramine

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Pharmacologic Actions
Antidepressive Agents, Tricyclic
Imipramine
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009