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THE EFFICACY OF PAROXETINE AND COGNITIVE-BEHAVIOURAL THERAPY IN THE TREATMENT OF LATE-LIFE PANIC DISORDER: A RANDOMIZED CONTROLLED TRIAL.


- candidate number2915
- NTR NumberNTR1144
- ISRCTNISRCTN wordt niet aangevraagd/retrospectief
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2007
- Secondary IDs9803-0063. CCMO-Arnhem/Nijmegen
- Public TitleTHE EFFICACY OF PAROXETINE AND COGNITIVE-BEHAVIOURAL THERAPY IN THE TREATMENT OF LATE-LIFE PANIC DISORDER: A RANDOMIZED CONTROLLED TRIAL.
- Scientific TitleTHE EFFICACY OF PAROXETINE AND COGNITIVE-BEHAVIOURAL THERAPY IN THE TREATMENT OF LATE-LIFE PANIC DISORDER: A RANDOMIZED CONTROLLED TRIAL.
- ACRONYMN/A
- hypothesis1. 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) studiedPanic disorder
- Inclusion criteria1. Panic disorder with/without agoraphobia (DSM-IV-criteria);
2. >60 years.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1999
- planned closingdate1-sep-2006
- Target number of participants80
- Interventions1. 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 outcomeSelf-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 outcomeSelf-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).
- TimepointsAssessments were completed at:
1. Week 0;
2. Week 8;
3. Week 14;
4. Week 26.
- Trial web siteN/A
- statusinclusion 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
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD27-nov-2007 - 2-dec-2008


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