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

April 29, 2010
May 17, 2010
January 2000
December 2002   (final data collection date for primary outcome measure)
  • 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%
Same as current
Complete list of historical versions of study NCT01114100 on ClinicalTrials.gov Archive Site
  • 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
  • HADS reduction score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    reduction in Hospital Anxiety and Depression Score
  • CGI improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    improvement in Clinical Global Impression Scale
  • EuroQol score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    improvement of Quality of Life measured by the EuroQol
  • 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
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Panic Attacks
  • Chest Pain
  • Depression
  • 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
  • Drug: placebo
    patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
    Other Name: placebo
  • Active Comparator: sertraline, panic education
    treatment with sertraline after panic education
    Intervention: Drug: sertraline
  • Placebo Comparator: placebo after panic education
    treatment with placebo after panic education
    Intervention: Drug: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
December 2002
December 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01114100
MEC99-128
No
Pfizer, Prof dr A Honig
Maastricht University Medical Center
Pfizer
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
Maastricht University Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP