Trial · NCT00590863
Combining Medications to Enhance Depression Outcomes
NCT00590863, Phase 4, Completed, National Institute of Mental Health (NIMH); results first posted 2014-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combining Medications to Enhance Depression Outcomes. Trials, record NCT00590863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00590863
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combining Medications to Enhance Depression Outcomes
- NCT number
- NCT00590863
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 665 participants, actual
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Conditions
- Major Depressive Disorder
- Interventions
- SSRI + placebo, Escitalopram + Bupropion SR, Venlafaxine XR + Mirtazapine
- First posted
- 2008-01-11
- Last updated
- 2014-04-23
- Results first posted
- 2014-04-23
- Limitations and caveats
Detailed results avaiable. A. J. Rush et al. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and long-term outcomes: a single-blind randomized study. American Journal of Psychiatry, 2011; 168:689-701.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quick Inventory of Depressive Symptoms | Measured at Month 7 | Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe). |
| Secondary | Quality of Life Inventory | Measured at Month 7 | The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quick Inventory of Depressive Symptoms | Measured at Month 7 | Remission = Last 2 QIDS \< 6. A chi-square test was used to compare the remission rates across the treatment groups. The Fisher's exact test was used when expected cell frequencies were \<5. For binary outcomes (e.g., remission), bivariate logistic regression models were fit to estimate the effect of treatment on outcome. | percentage of participants | NUMBER |
| SECONDARY | Quality of Life Inventory | Measured at Month 7 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quick Inventory of Depressive Symptoms | Escitalopram + Bupropion SR | 46.6 | 5.6 | percentage of participants | |
| Quick Inventory of Depressive Symptoms | Venlafaxine XR + Mirtazapine | 41.8 | percentage of participants | ||
| Quick Inventory of Depressive Symptoms | Escitalopram + Placebo | 46.0 | 5.4 | percentage of participants | |
| Quality of Life Inventory | Escitalopram + Bupropion SR | 0.6 | Standard Deviation 2.1 | units on a scale | |
| Quality of Life Inventory | Venlafaxine XR + Mirtazapine | 0.4 | Standard Deviation 2.4 | units on a scale | |
| Quality of Life Inventory | Escitalopram + Placebo | 0.4 | Standard Deviation 2.6 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Escitalopram + Bupropion SR | 221 | |
| Overall Study | STARTED | Venlafaxine XR + Mirtazapine | 220 | |
| Overall Study | STARTED | Escitalopram + Placebo | 224 | |
| Overall Study | COMPLETED | Escitalopram + Bupropion SR | 137 | |
| Overall Study | COMPLETED | Venlafaxine XR + Mirtazapine | 138 | |
| Overall Study | COMPLETED | Escitalopram + Placebo | 146 | |
| Overall Study | NOT COMPLETED | Escitalopram + Bupropion SR | 84 | |
| Overall Study | NOT COMPLETED | Venlafaxine XR + Mirtazapine | 82 | |
| Overall Study | NOT COMPLETED | Escitalopram + Placebo | 78 |
Source ClinicalTrials.gov
Adverse events39
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 |
|---|---|---|---|---|---|---|
| serious | Death, non-suicide | General disorders | Escitalopram + Bupropion SR | 0 | 221 | 0 |
| serious | Death, non-suicide | General disorders | Venlafaxine XR + Mirtazapine | 0 | 220 | 0 |
| serious | Death, non-suicide | General disorders | Escitalopram + Placebo | 1 | 224 | 1 |
| serious | Medial Hospitialization | Cardiac disorders | Escitalopram + Bupropion SR | 2 | 221 | 2 |
| serious | Medial Hospitialization | Cardiac disorders | Venlafaxine XR + Mirtazapine | 5 | 220 | 5 |
| serious | Medial Hospitialization | Cardiac disorders | Escitalopram + Placebo | 5 | 224 | 5 |
| serious | Medical Event, not requiring hospitalizaion | Cardiac disorders | Escitalopram + Bupropion SR | 0 | 221 | 0 |
| serious | Medical Event, not requiring hospitalizaion | Cardiac disorders | Venlafaxine XR + Mirtazapine | 0 | 220 | 0 |
| serious | Medical Event, not requiring hospitalizaion | Cardiac disorders | Escitalopram + Placebo | 1 | 224 | 1 |
| serious | Medical Event, not requiring hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Escitalopram + Bupropion SR | 0 | 221 | 0 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Escitalopram + Bupropion SR | ||
| Total, all-cause mortality | Venlafaxine XR + Mirtazapine | ||
| Total, all-cause mortality | Escitalopram + Placebo | ||
| Total, other adverse events | Escitalopram + Bupropion SR | 0 | 0 |
| Total, other adverse events | Venlafaxine XR + Mirtazapine | 0 | 0 |
| Total, other adverse events | Escitalopram + Placebo | 0 | 0 |
| Total, serious adverse events | Escitalopram + Bupropion SR | 12 | 221 |
| Total, serious adverse events | Venlafaxine XR + Mirtazapine | 16 | 220 |
| Total, serious adverse events | Escitalopram + Placebo | 13 | 224 |
Source ClinicalTrials.gov
Papers20
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01MH090003 | TREATMENT RESISTANT DEPRESSION-278990003 | UNIVERSITY OF TEXAS SW MED CTR | NATIONAL INSTITUTE OF MENTAL HEALTH | 1999 to 2003 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00590863
GET https://conductscience.org/api/trials/v1/NCT00590863/events?page=2