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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
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
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
Maastricht University Medical Centre
Maastricht, Netherlands
panic attacks
reduction of panic attacks by more than or equal to 50%
Time frame: 24 weeks
17 items Hamilton depression (HAMD) rating scale score
reduction of HAMD score of \>50%
Time frame: 24 weeks
Hospital Anxiety and Depression Scale (HADS)reduction score
reduction in Hospital Anxiety and Depression Score
Time frame: 24 weeks
Clinical Global Impression (CGI) improvement
improvement in Clinical Global Impression Scale
Time frame: 24 weeks
EuroQol (EQ-5D)score
improvement of Quality of Life measured by the EuroQol
Time frame: 24 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
improvement of Quality of Life measured by the SF 36
Time frame: 24 weeks
health care costs
decrease of health care costs using a diary for health costs
Time frame: 24 weeks
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