The Effects of Treatment With Sertraline for Noncardiac Chest Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01114100
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : May 18, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Panic Attacks Chest Pain Depression Drug: sertraline Drug: placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2000
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: sertraline, panic education
treatment with sertraline after panic education
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 Name: sertraline, zoloft
Placebo Comparator: placebo after panic education
treatment with placebo after panic education
Drug: placebo
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
No Intervention: care as usual
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01114100

Maastricht University Medical Centre
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Study Chair: Adriaan Honig, Prof,MD,Phd Now: St Lucas and Andreas Hospital, Amsterdam, Netherlands
Principal Investigator: Petra Kuijpers, MD, PhD Maastricht University Medical Centre, Maastricht, the Netherlands

Responsible Party: Pfizer, Prof dr A Honig Identifier: NCT01114100     History of Changes
Other Study ID Numbers: MEC99-128
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by Maastricht University Medical Center:
chest pain
panic attacks
panic disorder
depressive disorder
non cardiac chest pain

Additional relevant MeSH terms:
Depressive Disorder
Chest Pain
Panic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anxiety Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs