|- candidate number||2915|
|- NTR Number||NTR1144|
|- ISRCTN||ISRCTN wordt niet aangevraagd/retrospectief|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2007|
|- Secondary IDs||9803-0063. CCMO-Arnhem/Nijmegen |
|- Public Title||THE EFFICACY OF PAROXETINE AND COGNITIVE-BEHAVIOURAL THERAPY IN THE TREATMENT OF LATE-LIFE PANIC DISORDER: A RANDOMIZED CONTROLLED TRIAL.|
|- Scientific Title||THE EFFICACY OF PAROXETINE AND COGNITIVE-BEHAVIOURAL THERAPY IN THE TREATMENT OF LATE-LIFE PANIC DISORDER: A RANDOMIZED CONTROLLED TRIAL.|
|- hypothesis||1. Both paroxetine and cognitive behavioural therapy (CBT) are effective in the treatment of late-life panic disorder;|
2. Differences in efficacy between paroxetine and CBT are small.
|- Healt Condition(s) or Problem(s) studied||Panic disorder|
|- Inclusion criteria||1. Panic disorder with/without agoraphobia (DSM-IV-criteria);|
2. >60 years.
|- Exclusion criteria||1. The presence of severe psychiatric disorders (e.g. psychosis, major depression, bipolar disorder);|
2. A severe somatic condition which would hinder appropriate application of CBT (e.g. severe cardiovascular disease);
3. A contraindication for prescribing paroxetine (e.g. co-occurring use of anti-coagulantia);
4. Current use of an antidepressant in an adequate dose;
5. Current and adequate psychological treatment;
6. Abuse or dependency of alcohol or psychoactive substances;
7. Dementia and a score of 23 or less on the Mini-Mental State Examination.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-1999|
|- planned closingdate||1-sep-2006|
|- Target number of participants||80|
|- Interventions||1. Treatment with paroxetine 20 mg 1dd2 during 14 weeks;|
2. Cognitive behavioural therapy according to a treatment manual for panic disorder during 14 weekly sessions;
3. A waiting-list control condition of 14 weeks.
For both active treatments, paroxetine and CBT, follow-up period is 12 weeks.
|- Primary outcome||Self-report instruments for anxiety cogntions and phobic avoidance: scores on the Dutch adaptations of the Agoraphobic Cognitions Questionnaire (ACQ) and the Mobility Inventory avoidance scale (MI).|
|- Secondary outcome||Self-report instruments for depression and general psychopathology. Depressive symptoms were assessed with the Dutch adaptation of the Beck Depression Inventory (BDI) and general psychopathology was assessed with the Dutch adaptation of the Symptom Checklist (SCL-90). |
|- Timepoints||Assessments were completed at:|
1. Week 0;
2. Week 8;
3. Week 14;
4. Week 26.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| G.J. Hendriks|
|- CONTACT for SCIENTIFIC QUERIES|| G.J. Hendriks|
|- Sponsor/Initiator ||University Medical Center St. Radboud, GGZ|
(Source(s) of Monetary or Material Support)
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||27-nov-2007 - 2-dec-2008|