Panic AttacksPhase 4NCT01114100
The Effects of Treatment With Sertraline for Noncardiac Chest Pain
A Phase 4 study testing sertraline in people with Panic Attacks and Chest Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Attacks, Chest Pain, Depression
- What is being tested?
- sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2000to Dec 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6202 AZ
About this study
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
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.
Read the 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
- Being tested
- sertraline, placebo
- Keywords
- chest pain, panic attacks, palpitations, depression, panic disorder, depressive disorder, non cardiac chest pain
- Medical subject headings
- Panic Disorder, Chest Pain, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called sertraline, zoloft
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
placeboDrug
patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
| Study group | Role | What they receive |
|---|---|---|
| sertraline, panic education | Active comparator | treatment with sertraline after panic education Receives: Drug: sertraline |
| placebo after panic education | Placebo comparator | treatment with placebo after panic education Receives: Drug: placebo |
| care as usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
panic attacks
reduction of panic attacks by more than or equal to 50%
Measured: 24 weeks
17 items Hamilton depression (HAMD) rating scale score
reduction of HAMD score of >50%
Measured: 24 weeks
Secondary outcomes (5)
Hospital Anxiety and Depression Scale (HADS)reduction score
reduction in Hospital Anxiety and Depression Score
Measured: 24 weeks
Clinical Global Impression (CGI) improvement
improvement in Clinical Global Impression Scale
Measured: 24 weeks
EuroQol (EQ-5D)score
improvement of Quality of Life measured by the EuroQol
Measured: 24 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
improvement of Quality of Life measured by the SF 36
Measured: 24 weeks
health care costs
decrease of health care costs using a diary for health costs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJan 2000
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic AttacksStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Adriaan Honig, Prof,MD,Phd, Study chair, Now: St Lucas and Andreas Hospital, Amsterdam, NetherlandsPetra Kuijpers, MD, PhD, Principal investigator, Maastricht University Medical Centre, Maastricht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114100
- Sponsor's protocol ID
- MEC99-128
- Status last verified
- May 2010
- First submitted
- 29 Apr 2010
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01114100
- Acronym / sponsor ID
- MEC99-128
- Conditions
- Panic Attacks, Chest Pain, Depression
- Keywords
- chest pain, panic attacks, palpitations, depression, panic disorder, depressive disorder, non cardiac chest pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sertraline, panic education | Active comparator | Drug: sertralinetreatment with sertraline after panic education |
| placebo after panic education | Placebo comparator | Drug: placebotreatment with placebo after panic education |
| care as usual | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineAlso: sertraline, zoloftstarting 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 | Drug | sertraline, panic education |
| placebopatients received 1 pill, according to their complaints the number of pills was increased to maximally 3 | Drug | placebo after panic education |
Primary outcome
panic attacks
Time frame: 24 weeks
reduction of panic attacks by more than or equal to 50%
17 items Hamilton depression (HAMD) rating scale score
Time frame: 24 weeks
reduction of HAMD score of >50%
5 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)reduction score
Time frame: 24 weeks
Clinical Global Impression (CGI) improvement
Time frame: 24 weeks
EuroQol (EQ-5D)score
Time frame: 24 weeks
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) score
Time frame: 24 weeks
health care costs
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
Related trials for Panic Attacks
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
Qigong and Multicomponent Exercise in Panic Disorder
Panic Disorder, Panic Disorder (With or Without Agoraphobia)
RecruitingObservational study
EEG Microstate Parameters and Neuroinflammatory Biomarkers in Patients With Treatment-Resistant Major Depressive Disorder Receiving ECT
Major Depression Moderate, Major Depression Severe
RecruitingObservational study
EEG Microstate and Neuroinflammatory Biomarkers in Older Age Patients With Major Depressive Disorder Receiving ECT
Major Depression Moderate, Major Depression Severe
Active, not recruiting
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriaan Honig, Prof,MD,Phd study chair
Now: St Lucas and Andreas Hospital, Amsterdam, Netherlands
Petra Kuijpers, MD, PhD principal investigator
Maastricht University Medical Centre, Maastricht, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline in people with Panic Attacks and Chest Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
panic attacks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.