The Effects of Treatment With Sertraline for Noncardiac Chest Pain

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01114100
First received: April 29, 2010
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Panic Attacks
Chest Pain
Depression
Drug: sertraline
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • panic attacks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    reduction of panic attacks by more than or equal to 50%

  • 17 items Hamilton depression (HAMD) rating scale score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    reduction of HAMD score of >50%


Secondary Outcome Measures:
  • Hospital Anxiety and Depression Scale (HADS)reduction score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    reduction in Hospital Anxiety and Depression Score

  • Clinical Global Impression (CGI) improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    improvement in Clinical Global Impression Scale

  • EuroQol (EQ-5D)score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    improvement of Quality of Life measured by the EuroQol

  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    improvement of Quality of Life measured by the SF 36

  • health care costs [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    decrease of health care costs using a diary for health costs


Enrollment: 210
Study Start Date: January 2000
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114100

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Pfizer
Investigators
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
  More Information

No publications provided

Responsible Party: Pfizer, Prof dr A Honig
ClinicalTrials.gov Identifier: NCT01114100     History of Changes
Other Study ID Numbers: MEC99-128
Study First Received: April 29, 2010
Last Updated: May 17, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Chest Pain
Depression
Depressive Disorder
Panic Disorder
Pain
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014