The Effects of Treatment With Sertraline for Noncardiac Chest Pain

Phase 4

Completed

• Conditions: Panic Attacks; Depression; Chest Pain
• Interventions: Drug: placebo; Drug: sertraline

• Registration Number: NCT01114100
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo after panic education	placebo	treatment with placebo after panic education
sertraline, panic education	sertraline	treatment with sertraline after panic education

Primary Outcome Measures

Name	Time	Method
panic attacks	24 weeks	reduction of panic attacks by more than or equal to 50%
17 items Hamilton depression (HAMD) rating scale score	24 weeks	reduction of HAMD score of \>50%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands