The Effects of Treatment With Sertraline for Noncardiac Chest Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Panic Attacks, Chest Pain, Depression

Intervention / Treatment
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* Drug: sertraline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sertraline, panic education<br>treatment with sertraline after panic education | Drug: sertraline<br>* 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<br>* Other names: sertraline, zoloft;|
| Placebo Comparator: placebo after panic education<br>treatment with placebo after panic education | Drug: placebo<br>* patients received 1 pill, according to their complaints the number of pills was increased to maximally 3<br>|
| No Intervention: care as usual<br>patient received no diagnosis an no panic education, they had a 24 weeks follow up with a visit at 12 weeks and 24 weeks to evaluate their complaints | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| panic attacks | reduction of panic attacks by more than or equal to 50% | 24 weeks | 
| 17 items Hamilton depression (HAMD) rating scale score | reduction of HAMD score of >50% | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS)reduction score | reduction in Hospital Anxiety and Depression Score | 24 weeks | 
| Clinical Global Impression (CGI) improvement | improvement in Clinical Global Impression Scale | 24 weeks | 
| EuroQol (EQ-5D)score | improvement of Quality of Life measured by the EuroQol | 24 weeks | 
| Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score | improvement of Quality of Life measured by the SF 36 | 24 weeks | 
| health care costs | decrease of health care costs using a diary for health costs | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest pain, panic attacks, palpitations, depression, panic disorder, depressive disorder, non cardiac chest pain