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Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg daily or placebo, followed by 8 weeks of open-label mirtazapine 15 mg daily
Double-blind randomized controlled trials of 8 weeks mirtazapine 15 mg or placebo, followed by 8 weeks of open-label mirtazapine
Two weeks run-in, 8 weeks randomized, 8 weeks open label
Assessments include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirtazapine | Active Comparator | mirtazapine 15 mg daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirtazapine | Drug | Mirtazapine 15 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in dyspepsia symptom scores week 8 versus week 0 | The Dyspepsia Symptom Score is calculated from the dyspepsia symptom severity questionnaire at weeks 0, 4 and 8. The symptom score has been used in previous studies (Tack et al., Gastroenterology 1998). | Week 8 compared to week 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Individual symptom severities | Individual symptom scores from the dyspepsia symptom score (DSS) which is used as primary endpoint | Week 8 compared to week 0 |
| Nepean dyspepsia index for quality of life in functional dyspepsia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, M.D., Ph.D. | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals | Leuven | Flanders | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26538208 | Derived | Tack J, Ly HG, Carbone F, Vanheel H, Vanuytsel T, Holvoet L, Boeckxstaens G, Caenepeel P, Arts J, Van Oudenhove L. Efficacy of Mirtazapine in Patients With Functional Dyspepsia and Weight Loss. Clin Gastroenterol Hepatol. 2016 Mar;14(3):385-392.e4. doi: 10.1016/j.cgh.2015.09.043. Epub 2015 Oct 30. |
| Label | URL |
|---|---|
| Website Research Group | View source |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Use of the validated NDI.
| Week 8 compared to week 0 |