Back to resultsThe Effects of Treatment With Sertraline for Noncardiac Chest Pain
Primary Purpose
Panic Attacks, Chest Pain, Depression
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
sertraline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Panic Attacks focused on measuring chest pain, panic attacks, palpitations, depression, panic disorder, depressive disorder, non cardiac chest pain
Eligibility 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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
sertraline, panic education
placebo after panic education
care as usual
Arm Description
treatment with sertraline after panic education
treatment with placebo after panic education
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
Outcomes
Primary Outcome Measures
panic attacks
reduction of panic attacks by more than or equal to 50%
17 items Hamilton depression (HAMD) rating scale score
reduction of HAMD score of >50%
Secondary Outcome Measures
Hospital Anxiety and Depression Scale (HADS)reduction score
reduction in Hospital Anxiety and Depression Score
Clinical Global Impression (CGI) improvement
improvement in Clinical Global Impression Scale
EuroQol (EQ-5D)score
improvement of Quality of Life measured by the EuroQol
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
improvement of Quality of Life measured by the SF 36
health care costs
decrease of health care costs using a diary for health costs
Full Information
NCT ID
NCT01114100
First Posted
April 29, 2010
Last Updated
May 17, 2010
Sponsor
Maastricht University Medical Center
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01114100
Brief Title
The Effects of Treatment With Sertraline for Noncardiac Chest Pain
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 Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Attacks, Chest Pain, Depression
Keywords
chest pain, panic attacks, palpitations, depression, panic disorder, depressive disorder, non cardiac chest pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sertraline, panic education
Arm Type
Active Comparator
Arm Description
treatment with sertraline after panic education
Arm Title
placebo after panic education
Arm Type
Placebo Comparator
Arm Description
treatment with placebo after panic education
Arm Title
care as usual
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
sertraline
Other Intervention Name(s)
sertraline, zoloft
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
Primary Outcome Measure Information:
Title
panic attacks
Description
reduction of panic attacks by more than or equal to 50%
Time Frame
24 weeks
Title
17 items Hamilton depression (HAMD) rating scale score
Description
reduction of HAMD score of >50%
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)reduction score
Description
reduction in Hospital Anxiety and Depression Score
Time Frame
24 weeks
Title
Clinical Global Impression (CGI) improvement
Description
improvement in Clinical Global Impression Scale
Time Frame
24 weeks
Title
EuroQol (EQ-5D)score
Description
improvement of Quality of Life measured by the EuroQol
Time Frame
24 weeks
Title
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
Description
improvement of Quality of Life measured by the SF 36
Time Frame
24 weeks
Title
health care costs
Description
decrease of health care costs using a diary for health costs
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriaan Honig, Prof,MD,Phd
Organizational Affiliation
Now: St Lucas and Andreas Hospital, Amsterdam, Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Petra Kuijpers, MD, PhD
Organizational Affiliation
Maastricht University Medical Centre, Maastricht, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
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The Effects of Treatment With Sertraline for Noncardiac Chest Pain
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