Trial | NCT01114100  Report issue

Title

The Effects of Treatment With Sertraline for Noncardiac Chest Pain
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sertraline ...

  • Study Participants

    210
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 Started
Jan 31
2000
Primary Completion
Dec 31
2002
Study Completion
Dec 31
2002
Last Update
May 18
2010
Estimate

Drug sertraline

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

  • Other names: sertraline, zoloft

Drug placebo

patients received 1 pill, according to their complaints the number of pills was increased to maximally 3

sertraline, panic education Active Comparator

treatment with sertraline after panic education

placebo after panic education Placebo Comparator

treatment with placebo after panic education

care as usual No Intervention

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

Criteria 

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
No Results Posted