Condition category
Mental and Behavioural Disorders
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
04/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P P Mersch

ORCID ID

Contact details

University Medical Center Groningen
Department of Psychiatry
P.O. Box 30001
Rotterdam
9700 RB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STL-NL-96-002

Study information

Scientific title

Acronym

Study hypothesis

Baseline variables such as harm avoidance and other personality, biological and electrophysiological measures will predict treatment outcome to an Selective Serotonin Reuptake Inhibitor (SSRI).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Panic disorder

Intervention

Intervention:
Treatment with Sertraline (50 mg) for a period of 57 weeks

Investigators Assessments:
Hamilton Anxiety Scale
Hamilton Depression Scale
Clinical Global Impression

Subject’s assessments:
Frequency of panic attacks
Fear Questionnaire
Patient Global Evaluation
Symptoms CheckList (SCL-90)
Temperament and Character Inventory
NEO-Neuroticism subscale
Rand 36-item health survey
Rosenberg Self-esteem list

Biochemical assessments:
Plasma 3-Methoxy-4-HydroxyPhenylGlycol (MHPG) level
Plasma Sertraline level

Electrophysiology:
Heart Rate Variability

Intervention type

Drug

Phase

Not Specified

Drug names

Sertraline

Primary outcome measures

To identify variables mentioned above (at baseline) that can predict short-term and long-term response to treatment with sertraline in Panic Disorder.

Secondary outcome measures

1. To establish whether Autonomous Nervous System (ANS) functioning is a state marker of illness severity.
2. To establish whether treatment with sertraline has an affect on the functioning of the ANS.

Overall trial start date

01/06/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Panic Disorder According to Diagnostic and Statistical Manual of mental disorders (DSM-IV)
2. Two panic attacks in medication-free run-in period
3. Outpatients more than 18 years

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

57

Participant exclusion criteria

1. Co-morbid psychotic disorder, alcohol abuse, major affective disorder or personality disorder in the last year
2. Participation in other drug trial 30 days prior to selection
3. Serious medical illness
4. History of hepatitis
5. Risk of suicidality
6. History of drug allergy of hypersensitivity to SSRIs
7. Pregnancy, lactation or childbearing potential during the study

Recruitment start date

01/06/2002

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Rotterdam
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (The Netherlands)

Sponsor details

Room 5.29
Department of Psychiatry
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Pfizer

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes