|- candidate number||2214|
|- NTR Number||NTR753|
|- Date ISRCTN created||22-nov-2006|
|- date ISRCTN requested||8-nov-2006|
|- Date Registered NTR||22-aug-2006|
|- Secondary IDs||STL-NL-96-002 |
|- Public Title||The prediction of short-term and long-term treatment response to sertraline in panic disorder.|
|- Scientific Title||The prediction of short-term and long-term treatment response to sertraline in panic disorder.|
|- hypothesis||Baseline 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) studied||Panic disorder|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jun-2002|
|- planned closingdate||31-dec-2005|
|- Target number of participants||57|
|- Interventions||Treatment with Sertraline (50 mg) for a period of 57 weeks.|
1. Hamilton Anxiety Scale;
2. Hamilton Depression Scale,
3.Clinical Global Impression.
1. Frequency of panic attacks;
2. Fear Questionnaire;
3. Patient Global Evlauation;
5. Temperament and Character Inventory;
6. NEO-Neuroticism subscale;
7. Rand 36-item health survey;
8. Rosenberg Self-esteem list.
1. Plasma MHPG level, Plasma Sertraline level;
2. Electrophysiology: Heart Rate Variability
|- 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.
|- Trial web site||N/A|
|- status||inclusion 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|
(Source(s) of Monetary or Material Support)
|- Publications||In preparation.|
|- Brief summary||Phase I: |
This phase starts with a 2-week no-treatment run-in period.
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.
All other patients will be treated for 6 month and will enter a gradual drug taper, based upon clinical judgement.
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)|
|- RECORD||22-aug-2006 - 9-okt-2008|