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
Subjects 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
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