The Effects of Treatment With Sertraline for Panic Disorder and/or Depression Driven Chest Pain and/or Palpitations in a Double Blind, Care as Usual and Placebo Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- sertraline
- Conditions
- Panic Attacks
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- panic attacks
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to determine whether care as usual or intervention (consisting of sertraline versus placebo), are effective in the treatment of panic disorder and/or depression driven noncardiac chest pain.
Detailed Description
Noncardiac chest pain remains an important problem in clinical cardiology. Often, panic disorder and/or depression are the underlying cause. However, this is largely underdiagnosed. There are no clear existing treatment strategies/methods for this specific patient population. In our double blind, placebo controlled care as usual versus sertraline study, we want to investigate whether intervention is more effective as care as usual for diminishing chest pain, and also if sertraline is more effective in this specific population compared to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •chest pain without a cardiac cause
- •diagnosed with panic disorder and or depression according to Diagnostic and statistical Manual (DSM) IV criteria
- •Living \< 50 km from the hospital
- •informed consent
Exclusion Criteria
- •other primary DSM IV diagnosis
- •known sensitivity to sertraline
- •using other anti-depressive agents
- •not speaking dutch language
- •living in a nursery home or having dementia
- •other severe, acute or progressive disease, kidney or liver-function disturbances, pregnancy or breastfeeding
Arms & Interventions
sertraline, panic education
treatment with sertraline after panic education
Intervention: sertraline
placebo after panic education
treatment with placebo after panic education
Intervention: placebo
Outcomes
Primary Outcomes
panic attacks
Time Frame: 24 weeks
reduction of panic attacks by more than or equal to 50%
17 items Hamilton depression (HAMD) rating scale score
Time Frame: 24 weeks
reduction of HAMD score of \>50%
Secondary Outcomes
- Hospital Anxiety and Depression Scale (HADS)reduction score(24 weeks)
- Clinical Global Impression (CGI) improvement(24 weeks)
- EuroQol (EQ-5D)score(24 weeks)
- Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score(24 weeks)
- health care costs(24 weeks)