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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sertraline, panic education | Active Comparator | treatment with sertraline after panic education |
|
| placebo after panic education | Placebo Comparator | treatment 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriaan Honig, Prof,MD,Phd | Now: St Lucas and Andreas Hospital, Amsterdam, Netherlands | Study Chair |
| Petra Kuijpers, MD, PhD | Maastricht University Medical Centre, Maastricht, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | 6202 AZ | Netherlands |
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| ID | Term |
|---|---|
| D016584 | Panic Disorder |
| D002637 | Chest Pain |
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
| placebo | Drug | patients received 1 pill, according to their complaints the number of pills was increased to maximally 3 |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |