The Effect of Imipramine on Early Information Processing

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206999
• Other study ID #: 363052-2
• Secondary ID: KF 01-305/99KF 1
• Status: Completed
• Phase: N/A
• First received: September 11, 2005
• Last updated: September 19, 2011
• Start date: September 2004
• Est. completion date: January 2006

Study information

• Verified date: September 2011
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Denmark	Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup	Glostrup

Sponsors (5)

Lead Sponsor	Collaborator
Birte Glenthoj	Glostrup University Hospital, Copenhagen, Lundbeck Foundation, The Danish Medical Research Council, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory gating		Once, 1 hour after administration of capsule	No
Secondary	PPI of the startle reflex		once, one hour after administration	No
Secondary	P50 suppression		once, one hour after administration	No

External Links

•   Center for Neuropsychiatric Schizophrenia Research (CNSR)