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Treatment of Non-Cardiac Chest Pain With Imipramine or Cognitive-Behavioral Therapy

Psychophysiological Interactions in Non-Cardiac Chest Pain

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005575
Enrollment
Unknown
Registered
2000-05-02
Start date
1999-01-31
Completion date
2002-12-31
Last updated
2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

Keywords

Imipramine, Cognitive-Behavioral Therapy

Brief summary

Approximately 75,000-150,000 patients each year in the United States undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. These patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimated health care costs each year. There is some evidence from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of training in pain coping skills and cognitive-behavioral therapy (CBT) both produce short-term reductions in pain intensity. However, no studies have compared the effects of these two treatments on measures of pain, suffering, and disability at post-treatment and over a one-year follow-up period. Our investigation is a 16-week, randomized controlled outcome study of these interventions and their respective placebo control procedures. One hundred and sixty patients are being recruited for this study. We will assess the effects of our interventions on patients' pain levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month follow-up, and at 12-month follow-up. We will evaluate the clinical significance of our treatment effects as well as their statistical significance.

Interventions

DRUGImipramine

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Substernal chest pain at least 2X per week for at least 3 months; * Angiographic evidence of normal or non-obstructive (\<50% luminal diameter narrowing) coronary arteries among subjects \> 40 years of age; OR Normal exercise stress tests, normal echocardiogram, and cardiologist evaluation that symptoms are not cardiac in origin among subjects \< 40 years of age; * Gastroesophageal reflux disease ruled out by 24-hour pH monitoring, endoscopy, or 1-month trial of anti-reflux therapy with omeprazole 20 mg bid; * Pain threshold levels for esophageal balloon distention must be 12 ml.

Exclusion criteria

* Mitral valve prolapse

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026