The Effect of Imipramine on Early Information Processing

Sponsor

Birte Glenthoj (Other)

Overall Status

Completed

CT.gov ID

NCT00206999

Collaborator

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

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: imipramine	N/A

Detailed Description

Schizophrenic patients exhibit impairments in filtering of sensory information, as can be assessed by use of prepulse inhibition (PPI) of the acoustic startle response and P50 suppression paradigms. In the treatment of negative symptoms or depressive syndromes during the course of schizophrenia antidepressants are often combined with antipsychotic medication. However, antidepressants increase monoaminergic activity, of which in turn it has been suggested to decrease sensory gating, although these presumptions are mostly based on results from animal studies. Currently, little is known about monoaminergic modulation of sensory filtering in humans, and the few reports that can be found in literature show discrepancies with animal studies. The current study was designed to study the effects of increased monoaminergic activity on sensory filtering and habituation of healthy volunteers. In a double-blind, placebo controlled cross-over design, twenty healthy male volunteers will receive either placebo or a dose of 50 mg of imipramine (a dual acting antidepressant), after which they will be tested in a P50 suppression-, a PPI-, and a habituation of the startle reflex paradigm.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: imipramine Either 50 mg of imipramine or placebo will be administered to healthy male volunteers

Arm

Intervention/Treatment

Experimental: 1

Drug: imipramine

Either 50 mg of imipramine or placebo will be administered to healthy male volunteers

Outcome Measures

Primary Outcome Measures

Sensory gating [Once, 1 hour after administration of capsule]

Secondary Outcome Measures

PPI of the startle reflex [once, one hour after administration]
P50 suppression [once, one hour after administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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 ecstasy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup	Glostrup		Denmark	DK-2600

Sponsors and Collaborators

Birte Glenthoj
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