The Effects of Treatment With Sertraline for Noncardiac Chest Pain

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114100
• Other study ID #: MEC99-128
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2010
• Last updated: May 17, 2010
• Start date: January 2000
• Est. completion date: December 2002

Study information

• Verified date: May 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Depression
• Depressive Disorder
• Panic Attacks

Intervention

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
• placebo
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	panic attacks	reduction of panic attacks by more than or equal to 50%	24 weeks	No
Primary	17 items Hamilton depression (HAMD) rating scale score	reduction of HAMD score of >50%	24 weeks	No
Secondary	Hospital Anxiety and Depression Scale (HADS)reduction score	reduction in Hospital Anxiety and Depression Score	24 weeks	No
Secondary	Clinical Global Impression (CGI) improvement	improvement in Clinical Global Impression Scale	24 weeks	No
Secondary	EuroQol (EQ-5D)score	improvement of Quality of Life measured by the EuroQol	24 weeks	No
Secondary	Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score	improvement of Quality of Life measured by the SF 36	24 weeks	No
Secondary	health care costs	decrease of health care costs using a diary for health costs	24 weeks	No