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Completed

NCT Number: NCT01114100

The Effects of Treatment With Sertraline for Noncardiac Chest Pain

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.

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Key information

Conditions

Panic Attacks Anxiety Disorders Behavior Behavioral Symptoms Chest Pain Depression Depressive Disorder Mental Disorders Mood Disorders Neurologic Manifestations Pain Panic Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Centre

Maastricht, 6202 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertraline

Drug

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

Placebo

Drug

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

Primary outcomes

  1. panic attacks

    Time frame: 24 weeks

    reduction of panic attacks by more than or equal to 50%

  2. 17 items Hamilton depression (HAMD) rating scale score

    Time frame: 24 weeks

    reduction of HAMD score of >50%

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)reduction score

    Time frame: 24 weeks

    reduction in Hospital Anxiety and Depression Score

  2. Clinical Global Impression (CGI) improvement

    Time frame: 24 weeks

    improvement in Clinical Global Impression Scale

  3. EuroQol (EQ-5D)score

    Time frame: 24 weeks

    improvement of Quality of Life measured by the EuroQol

  4. Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score

    Time frame: 24 weeks

    improvement of Quality of Life measured by the SF 36

  5. health care costs

    Time frame: 24 weeks

    decrease of health care costs using a diary for health costs

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Apr 30, 2010
Registry last updated
May 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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