Modulation of Visually Evoked Potentials by an Antidepres... | NCT00263133

Studies
Modulation of Visually Evoked Potentials by an Antidepressant

NCT00263133

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Jun 4, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Depression

Interventions

Sertraline

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2005-005417-37

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Jan 2006

First Submitted Date

Dec 6, 2005

First Submission Date that Met QC Criteria

Dec 6, 2005

First Posted Date

Dec 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2007

Last Update Posted Date

Jun 4, 2007Estimated

Description Module

Brief Summary

12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. This study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Sertraline	Drug

Measure	Description	Time Frame
Amplitudes and latencies of early visually evoked potentials.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals 18-65 years

Exclusion Criteria:

history of affective oder other psyhiatric disorder
severe medical condition
pregnancy or ineffective contraception
active illicit drug use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claus Normann, MD	Dept. of Psychiatry, University of Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Psychiatry, University of Freiburg		Freiburg im Breisgau		79104	Germany

ID	Term
D003863	Depression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D020280	Sertraline

Ancestor Terms

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes

Browse Leaves

Not provided

Browse Branches

Not provided