No registrations found.
ID
Source
Brief title
Health condition
Outpatient study at the University Outpatient Clinic, Department of Psychiatry Groningen.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Phase I:
This phase starts with a 2-week no-treatment run-in period.
Phase II:
Open-label treatment with Sertraline of three months (until visit 7, day 85). Non-responders to short-term treatment with Sertraline will discontinue from the study at this point.
Phase III:
All other patients will be treated for 6 month and will enter a gradual drug taper, based upon clinical judgement.
Phase IV:
From visit 9 onwards, after drug taper-off, treatment will be naturalistic. At visit 10 (day 3666) a clinical follow-up evaluation will be performed.
Study objective
Baseline variables such as Harm Avoidance and other personality, biological and electrophysiological measures will predict treatment outocme to an SSRI.
Study design
N/A
Intervention
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
P.O. Box 30.001
Johan A. Boer den
Groningen 9700 RB
The Netherlands
m.jongsma@psy.umcg.nl
P.O. Box 30.001
Johan A. Boer den
Groningen 9700 RB
The Netherlands
m.jongsma@psy.umcg.nl
Inclusion criteria
1. Panic Disorder According to DSM-IV.
2. 2 panic attacks in medication-free run-in period.
3. Outpatients >18yrs.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL743 |
| NTR-old | NTR753 |
| Other | : STL-NL-96-002 |
| ISRCTN | ISRCTN03447252 |