The Effects of Treatment With Sertraline for Noncardiac Chest Pain
NCT01114100
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | |||||||
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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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |