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The prediction of short-term and long-term treatment response to sertraline in panic disorder.


- candidate number2214
- NTR NumberNTR753
- ISRCTNISRCTN03447252
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR22-aug-2006
- Secondary IDsSTL-NL-96-002 
- Public TitleThe prediction of short-term and long-term treatment response to sertraline in panic disorder.
- Scientific TitleThe prediction of short-term and long-term treatment response to sertraline in panic disorder.
- ACRONYMN/A
- hypothesisBaseline variables such as Harm Avoidance and other personality, biological and electrophysiological measures will predict treatment outocme to an SSRI.
- Healt Condition(s) or Problem(s) studiedPanic disorder
- Inclusion criteria1. Panic Disorder According to DSM-IV.
2. 2 panic attacks in medication-free run-in period.
3. Outpatients >18yrs.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-jun-2002
- planned closingdate31-dec-2005
- Target number of participants57
- InterventionsTreatment 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
- Primary outcomeTo identify variables mentioned above (at baseline) that can predict short-term and long-term response to treatment with sertraline in Panic Disorder.
- Secondary outcomeTo 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Johan A. Boer den
- CONTACT for SCIENTIFIC QUERIES Johan A. Boer den
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of psychiatry
- Funding
(Source(s) of Monetary or Material Support)
Pfizer
- PublicationsIn preparation.
- Brief summaryPhase 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.
- Main changes (audit trail)
- RECORD22-aug-2006 - 9-okt-2008


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