The Effects of Treatment With Sertraline for Noncardiac Chest Pain
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2000
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 29, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedMay 18, 2010
May 1, 2010
2.9 years
April 29, 2010
May 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
panic attacks
reduction of panic attacks by more than or equal to 50%
24 weeks
17 items Hamilton depression (HAMD) rating scale score
reduction of HAMD score of \>50%
24 weeks
Secondary Outcomes (5)
Hospital Anxiety and Depression Scale (HADS)reduction score
24 weeks
Clinical Global Impression (CGI) improvement
24 weeks
EuroQol (EQ-5D)score
24 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
24 weeks
health care costs
24 weeks
Study Arms (3)
sertraline, panic education
ACTIVE COMPARATORtreatment with sertraline after panic education
placebo after panic education
PLACEBO COMPARATORtreatment with placebo after panic education
care as usual
NO INTERVENTIONpatient 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
Interventions
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
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Pfizercollaborator
Study Sites (1)
Maastricht University Medical Centre
Maastricht, 6202 AZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 29, 2010
First Posted
April 30, 2010
Study Start
January 1, 2000
Primary Completion
December 1, 2002
Study Completion
December 1, 2002
Last Updated
May 18, 2010
Record last verified: 2010-05