Outpatient study at the University Outpatient Clinic, Department of Psychiatry Groningen.
Conditions
Interventions
Treatment with Sertraline (50 mg) for a period of 57 weeks.
Investigators Assessments:
1. Hamilton Anxiety Scale
2. Hamilton Depression Scale,
3.Clinical Global Impression.
Subjects assessments:
1. Frequency of panic attacks
2. Fear Questionnaire
3. Patient Global Evlauation
4. SCL-90
5. Temperament and Character Inventory
6. NEO-Neuroticism subscale
7. Rand 36-item health survey
8. Rosenberg Self-esteem list.
Biochemical assessments:
1. Plasma MHPG level, Plasma Sertraline level
2. Electrophysiology: Heart Rate Variability
Sponsors
Pfizer
Eligibility
Inclusion criteria
Inclusion criteria: 1. Panic Disorder According to DSM-IV. 2. 2 panic attacks in medication-free run-in period. 3. Outpatients >18yrs.
Exclusion criteria
Exclusion criteria: 1. Comorbid psychotic disorder, alcolhol 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 SSRI's. 7. Pregnancy, lactation or childbearing potential during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify variables mentioned above (at baseline) that can predict short-term and long-term response to treatment with sertraline in Panic Disorder. | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish whether autonomous nervous system (ANS) functioning is a state marker of illness severity, and: to establish whether treatment with sertraline has an affect on the functioning of the ANS. | — |
Contacts
Public ContactJohan A. Boer den
University Medical Center Groningen, P.O. Box 30.001
Outcome results
None listed