The Effects of Treatment With Sertraline for Noncardiac Chest Pain

NCT01114100

Last updated date
Study Location
Maastricht University Medical Centre
Maastricht, , 6202 AZ, Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Attacks, Chest Pain, Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Panic Attacks, Chest Pain, DepressionThe Effects of Treatment With Sertraline for Noncardiac Chest Pain
NCT01114100
  1. Maastricht,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effects of Treatment With Sertraline for Noncardiac Chest Pain
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Panic Attacks
  • Chest Pain
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
210
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01114100
Other Study ID Numbers  ICMJE MEC99-128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer, Prof dr A Honig
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Adriaan Honig, Prof,MD,PhdNow: St Lucas and Andreas Hospital, Amsterdam, Netherlands
Principal Investigator:Petra Kuijpers, MD, PhDMaastricht University Medical Centre, Maastricht, the Netherlands
PRS Account Maastricht University Medical Center
Verification Date May 2010

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