The Effects of Treatment With Sertraline for Noncardiac Chest Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Chest Pain; Panic Attacks
• Intervention / Treatment: Drug: sertraline; Drug: placebo

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: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sertraline, panic education; treatment with sertraline after panic education	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 Names: sertraline, zoloft
Placebo Comparator: placebo after panic education; treatment with placebo after panic education	Drug: placebo; patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)reduction score	reduction in Hospital Anxiety and Depression Score	24 weeks
Clinical Global Impression (CGI) improvement	improvement in Clinical Global Impression Scale	24 weeks
EuroQol (EQ-5D)score	improvement of Quality of Life measured by the EuroQol	24 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score	improvement of Quality of Life measured by the SF 36	24 weeks
health care costs	decrease of health care costs using a diary for health costs	24 weeks

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Pfizer
• Investigators: 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 record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2002
• Study Completion (Actual): December 1, 2002

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): May 18, 2010
• Last Update Submitted That Met QC Criteria: May 17, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: chest pain; depression; panic disorder; depressive disorder; palpitations; panic attacks; non cardiac chest pain
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Depression; Depressive Disorder; Chest Pain; Panic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: MEC99-128