Panic DisorderMADONANCT00736346
Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
A study testing Brief cognitive-behavioral treatment for Panic Disorder, Cognitive-Behavior Therapy for Panic Disorder and paroxetine in people with Panic Disorder and Anxiety Disorder, run by Université du Québec a Montréal at 3 sites in Canada.
Trial summary
The purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having Panic Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder, Anxiety Disorder, Mental Disorder
- What is being tested?
- Brief cognitive-behavioral treatment for Panic Disorder, Cognitive-Behavior Therapy for Panic Disorder and paroxetine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2005to Jun 2010
- Phase
- Interventional
- 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
- Aged 18 and over
- Mastered oral and written French
- Consulted an emergency department for chest pain with very low risk of coronary disease (normal ECG and blood tests)
- Met criteria for Panic Disorder
Who cannot join
- Chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays)
- Had received cognitive-behavior therapy for Panic Disorder in the last six months
- Cognitive impairment preventing the completion of psychological assessment
- Past or present psychotic episode, Bipolar Disorder, or organic mental disorder
- Current Abuse or Dependence Disorder
- If another Mental Disorder is present, its severity was equal or inferior to the severity of Panic Disorder
- Current medical condition preventing the participant from receiving pharmacological of cognitive-behavior treatment
Trial locations and contacts
3 sites in 1 country.
Geneviève Belleville, PhD contact
Canada3 sites, 3 recruiting
- Recruiting
Hôtel-Dieu de Lévis
Lévis, Quebec, G6V 3Z1
Julien Poitras, MD
- Recruiting
Institut de Cardiologie de Montréal (Montreal Heart Institute)
Montreal, Quebec, H1T 1C8
Alain Vadeboncoeur, MD
- Recruiting
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Jean-Marc Chauny, MD
About this study
Official title: Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
The purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having Panic Disorder.
- Conditions
- Panic Disorder, Anxiety Disorder, Mental Disorder
- Being tested
- Brief cognitive-behavioral treatment for Panic Disorder, Cognitive-Behavior Therapy for Panic Disorder, paroxetine
- Keywords
- Panic Disorder, anxiety, chest pain, emergency department, cognitive-behavioral treatment
- Medical subject headings
- Panic Disorder, Anxiety Disorders, Mental Disorders, Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief cognitive-behavioral treatment for Panic DisorderBehavioural
One two-hour session of cognitive-behavior therapy for panic disorder
Cognitive-Behavior Therapy for Panic DisorderBehavioural
Seven one-hour sessions of cognitive-behavior therapy for panic disorder
paroxetineDrug
40 mg die, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Brief cognitive-behavioral treatment for Panic Disorder |
| 2 | Active comparator | Not described Receives: Behavioral: Cognitive-Behavior Therapy for Panic Disorder |
| 3 | Active comparator | Not described Receives: Drug: paroxetine |
| 4 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic Disorder diagnosis
Measured: Pre and posttreatment, and 3, 6 and 12 months after treament
Secondary outcomes (1)
Panic symptomatology, psychological distress, quality of life, and use of health services
Measured: Pre and posttreatment, and 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startOct 2005
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- André Marchand, PhD, Principal investigator, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736346
- Sponsor's protocol ID
- MOP 81128 (CIHR)
- Acronym
- MADONA
- Status last verified
- Aug 2008
- First submitted
- 14 Aug 2008
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Foldes-Busque G, Hamel S, Belleville G, Fleet R, Poitras J, Chauny JM, Vadeboncoeur A, Lavoie KL, Marchand A. Factors associated with pain level in non-cardiac chest pain patients with comorbid panic disorder. Biopsychosoc Med. 2016 Oct 18;10:30. doi: 10.1186/s13030-016-0081-5. eCollection 2016.
PubMed 27777612
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain
- ClinicalTrials.gov ID
- NCT00736346
- Acronym / sponsor ID
- MADONA / MOP 81128 (CIHR)
- Conditions
- Panic Disorder, Anxiety Disorder, Mental Disorder
- Keywords
- Panic Disorder, anxiety, chest pain, emergency department, cognitive-behavioral treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2005
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 15 Aug 2008 (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 assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having Panic Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Brief cognitive-behavioral treatment for Panic Disorder |
| 2 | Active comparator | Behavioral: Cognitive-Behavior Therapy for Panic Disorder |
| 3 | Active comparator | Drug: paroxetine |
| 4 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 and over
- Mastered oral and written French
- Consulted an emergency department for chest pain with very low risk of coronary disease (normal ECG and blood tests)
- Met criteria for Panic Disorder
Key exclusion criteria (7 listed)
- Chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays)
- Had received cognitive-behavior therapy for Panic Disorder in the last six months
- Cognitive impairment preventing the completion of psychological assessment
- Past or present psychotic episode, Bipolar Disorder, or organic mental disorder
- Current Abuse or Dependence Disorder
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 |
|---|---|---|
| Brief cognitive-behavioral treatment for Panic DisorderOne two-hour session of cognitive-behavior therapy for panic disorder | Behavioural | 1 |
| Cognitive-Behavior Therapy for Panic DisorderSeven one-hour sessions of cognitive-behavior therapy for panic disorder | Behavioural | 2 |
| paroxetine40 mg die, for 6 months | Drug | 3 |
Primary outcome
Panic Disorder diagnosis
Time frame: Pre and posttreatment, and 3, 6 and 12 months after treament
1 secondary outcome
Panic symptomatology, psychological distress, quality of life, and use of health services
Time frame: Pre and posttreatment, and 3, 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2008.
- Derived from this study: PubMed 27777612Foldes-Busque G, Hamel S, Belleville G, Fleet R, Poitras J, Chauny JM, Vadeboncoeur A, Lavoie KL, Marchand A. Factors associated with pain level in non-cardiac chest pain patients with comorbid panic disorder. Biopsychosoc Med. 2016 Oct 18;10:30. doi: 10.1186/s13030-016-0081-5. eCollection 2016.
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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.
Geneviève Belleville, PhD contact
André Marchand, PhD principal investigator
Université du Québec a Montréal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief cognitive-behavioral treatment for Panic Disorder, Cognitive-Behavior Therapy for Panic Disorder and paroxetine in people with Panic Disorder and Anxiety Disorder, run by Université du Québec a Montréal at 3 sites in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 15 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Marchand, PhD (1 (514) 987-3000 ext. 8439, marchand.andre@uqam.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panic Disorder diagnosis (time frame: Pre and posttreatment, and 3, 6 and 12 months after treament). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736346, which also lists 1 linked publication.
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 15 Aug 2008.