Baseline variables such as Harm Avoidance and other personality, biological and electrophysiological measures will predict treatment outocme to an SSRI.
ID
Bron
Verkorte titel
Aandoening
Outpatient study at the University Outpatient Clinic, Department of Psychiatry Groningen.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To identify variables mentioned above (at baseline) that can predict short-term and long-term response to treatment with sertraline in Panic Disorder.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Baseline variables such as Harm Avoidance and other personality, biological and electrophysiological measures will predict treatment outocme to an SSRI.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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
Publiek
P.O. Box 30.001
Johan A. Boer den
Groningen 9700 RB
The Netherlands
m.jongsma@psy.umcg.nl
Wetenschappelijk
P.O. Box 30.001
Johan A. Boer den
Groningen 9700 RB
The Netherlands
m.jongsma@psy.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Panic Disorder According to DSM-IV.
2. 2 panic attacks in medication-free run-in period.
3. Outpatients >18yrs.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL743 |
NTR-old | NTR753 |
Ander register | : STL-NL-96-002 |
ISRCTN | ISRCTN03447252 |