The Effects of Treatment With Sertraline for Noncardiac Chest Pain

NCT ID: NCT01114100

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2002-12-31

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.

Conditions

Panic Attacks; Chest Pain; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sertraline, panic education

treatment with sertraline after panic education

Group Type: ACTIVE_COMPARATOR

sertraline

Intervention Type: DRUG

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 after panic education

treatment with placebo after panic education

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

sertraline, zoloft

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Prof dr A Honig

Principal Investigators

Adriaan Honig, Prof,MD,Phd

Role: STUDY_CHAIR

Now: St Lucas and Andreas Hospital, Amsterdam, Netherlands

Petra Kuijpers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre, Maastricht, the Netherlands

Locations

Maastricht University Medical Centre

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

MEC99-128

Identifier Type: -

Identifier Source: org_study_id