The Effects of Treatment With Sertraline for Noncardiac Chest Pain

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 4

Conditions: Chest Pain; Depression; Panic Attacks

Treatments: Drug: placebo; Drug: sertraline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01114100

MEC99-128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

sertraline, panic education

Active Comparator group

Description:

treatment with sertraline after panic education

Treatment:

Drug: sertraline

placebo after panic education

Placebo Comparator group

Description:

treatment with placebo after panic education

Treatment:

Drug: placebo

care as usual

No Intervention group

Description:

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