Chest Pain, Depression, Panic Attacks
Conditions
Keywords
chest pain, panic attacks, palpitations, depression, panic disorder, depressive disorder, non cardiac chest pain
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.
Interventions
DRUGsertraline
starting dose 25 mg for 1 week, the increasing to 50 mg, after each visit evaluation whether dosage has to be increased to maximally 150 mg
DRUGplacebo
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
Sponsors
Pfizer
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 17 items Hamilton depression (HAMD) rating scale score | 24 weeks | reduction of HAMD score of \>50% |
| panic attacks | 24 weeks | reduction of panic attacks by more than or equal to 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol (EQ-5D)score | 24 weeks | improvement of Quality of Life measured by the EuroQol |
| Hospital Anxiety and Depression Scale (HADS)reduction score | 24 weeks | reduction in Hospital Anxiety and Depression Score |
| health care costs | 24 weeks | decrease of health care costs using a diary for health costs |
| Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score | 24 weeks | improvement of Quality of Life measured by the SF 36 |
| Clinical Global Impression (CGI) improvement | 24 weeks | improvement in Clinical Global Impression Scale |
Countries
Netherlands
Outcome results
None listed