NCT00206999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

September 11, 2005

Last Update Submit

September 19, 2011

Conditions

Healthy Volunteers

Keywords

PsychophysiologyPPIP50 suppressionImipramine

Outcome Measures

Primary Outcomes (1)

  • Sensory gating

    Once, 1 hour after administration of capsule

Secondary Outcomes (2)

  • PPI of the startle reflex

    once, one hour after administration

  • P50 suppression

    once, one hour after administration

Study Arms (1)

1

EXPERIMENTAL
Drug: imipramine

Interventions

imipramineDRUG

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

1

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup Municipality, DK-2600, Denmark

Location

Related Links

MeSH Terms

Interventions

Imipramine

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 21, 2005

Study Start

September 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

DK(1)