Trial · NCT01165541
A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
NCT01165541, Phase 2, Completed, Dartmouth-Hitchcock Medical Center; results first posted 2014-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency. Trials, record NCT01165541. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01165541
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
- NCT number
- NCT01165541
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Alcohol Dependence
- Interventions
- Mirtazapine, Quetiapine fumarate extended release (Quetiapine XR)
- First posted
- 2010-07-20
- Last updated
- 2018-04-09
- Results first posted
- 2014-03-31
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Very Heavy Drinking Days Per Week | 14 Weeks | The number of "very heavy" drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Very Heavy Drinking Days Per Week | 14 Weeks | The Analysis Population only consists of participants that completed both phases of the study. | days | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Very Heavy Drinking Days Per Week | Quetiapine Fumarate Extended Release (Quetiapine XR) | 2.1 | Standard Deviation 2.8 | days | |
| Number of Very Heavy Drinking Days Per Week | Quetiapine XR Plus Mirtazapine | 1.3 | Standard Deviation 2.4 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Quetiapine XR Monotherapy | STARTED | Entire Study Population | 20 | |
| Quetiapine XR Monotherapy | COMPLETED | Entire Study Population | 16 | |
| Quetiapine XR Monotherapy | NOT COMPLETED | Entire Study Population | 4 | |
| Quetiapine XR and Mirtazepine | STARTED | Entire Study Population | 16 | |
| Quetiapine XR and Mirtazepine | COMPLETED | Entire Study Population | 11 | |
| Quetiapine XR and Mirtazepine | NOT COMPLETED | Entire Study Population | 5 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Prolonged QTC | Cardiac disorders | Quetiapine Fumarate Extended Release (Quetiapine XR) | 0 | 20 | 0 |
| other | Prolonged QTC | Cardiac disorders | Quetiapine XR andMirtazapine | 1 | 16 | 1 |
| other | Dermatological Condition | Skin and subcutaneous tissue disorders | Quetiapine Fumarate Extended Release (Quetiapine XR) | 2 | 20 | 2 |
| other | Dermatological Condition | Skin and subcutaneous tissue disorders | Quetiapine XR andMirtazapine | 1 | 16 | 1 |
| other | Dizzy | Nervous system disorders | Quetiapine Fumarate Extended Release (Quetiapine XR) | 6 | 20 | 6 |
| other | Dizzy | Nervous system disorders | Quetiapine XR andMirtazapine | 1 | 16 | 1 |
| other | Unusual Dream Activity | Psychiatric disorders | Quetiapine Fumarate Extended Release (Quetiapine XR) | 3 | 20 | 3 |
| other | Unusual Dream Activity | Psychiatric disorders | Quetiapine XR andMirtazapine | 1 | 16 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | Quetiapine Fumarate Extended Release (Quetiapine XR) | 7 | 20 | 7 |
| other | Dry Mouth | Gastrointestinal disorders | Quetiapine XR andMirtazapine | 2 | 16 | 2 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine Fumarate Extended Release (Quetiapine XR) | ||
| Total, all-cause mortality | Quetiapine XR andMirtazapine | ||
| Total, other adverse events | Quetiapine Fumarate Extended Release (Quetiapine XR) | 20 | 20 |
| Total, other adverse events | Quetiapine XR andMirtazapine | 14 | 16 |
| Total, serious adverse events | Quetiapine Fumarate Extended Release (Quetiapine XR) | 0 | 20 |
| Total, serious adverse events | Quetiapine XR andMirtazapine | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Quetiapine Fumarate Extended Release (Quetiapine XR) vs Quetiapine XR andMirtazapine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01165541
GET https://conductscience.org/api/trials/v1/NCT01165541/events?page=2