NCT00206934

Brief Summary

It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect information processing. Our hypothesis was that aspects of information processing would be disturbed whereas others would improve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

September 19, 2011

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

September 16, 2011

Conditions

Healthy Volunteers

Keywords

PPIP50 suppressionP300mismatch negativityescitalopram

Outcome Measures

Primary Outcomes (4)

  • The PPI (Prepulse Inhibition of the Startle Response) task

    Once, 3.5 hrs after intake of capsule

  • The P50 Suppression task

    Once, 3.5 hrs after intake of capsule

  • The P300 ERP task

    Once, 3.5 hrs after intake of capsule

  • The mismatch negativity (MMN) task

    Once, 3.5 hrs after intake of capsule

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Escitalopram

2

PLACEBO COMPARATOR
Drug: escitaolpram

Interventions

EscitalopramDRUG

Either 10 mg of escitalopram or placebo will be administered to a group of healthy volunteers

Also known as: Cipralex
1
escitaolpramDRUG

Either 15 mg of escitalopram or placebo will be administered to healthy volunteers

Also known as: Cipralex
2

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 esctacy.

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

EscitalopramDexetimide

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidonesPiperidinesHeterocyclic Compounds, 1-Ring

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

March 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

September 19, 2011

Record last verified: 2008-07

Locations

DK(1)