Trial Outcomes & Findings for Combining Medications to Enhance Depression Outcomes (NCT NCT00590863)
NCT ID: NCT00590863
Last Updated: 2014-04-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
665 participants
Primary outcome timeframe
Measured at Month 7
Results posted on
2014-04-23
Participant Flow
Participants were recruited from March 2008 through April of 2009, with the last subject completing the study in September 2009. Participants were recruited from six primary care and nine psychiatric care sites within the NIMH Depression Trials Network.
Outpatient enrollees, 18-75 years old, met DSM-IV-TR criteria for either recurrent or chronic MDD. Eligible participants had to be in the index episode for at least two months and to score ≥16 on the 17-item HAM-D. Those with any history of psychotic illness or bipolar disorder, or in need of hospitalization were ineligible.
Participant milestones
| Measure |
Escitalopram + Bupropion SR
Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
|
Venlafaxine XR + Mirtazapine
Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
|
Escitalopram + Placebo
Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
221
|
220
|
224
|
|
Overall Study
COMPLETED
|
137
|
138
|
146
|
|
Overall Study
NOT COMPLETED
|
84
|
82
|
78
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combining Medications to Enhance Depression Outcomes
Baseline characteristics by cohort
| Measure |
Escitalopram + Bupropion SR
n=221 Participants
Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
|
Venlafaxine XR + Mirtazapine
n=220 Participants
Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
|
Escitalopram + Placebo
n=224 Participants
Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
|
Total
n=665 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
221 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
665 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
452 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
221 participants
n=5 Participants
|
220 participants
n=7 Participants
|
224 participants
n=5 Participants
|
665 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 7Population: 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 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).
Outcome measures
| Measure |
Escitalopram + Bupropion SR
n=137 Participants
Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
|
Venlafaxine XR + Mirtazapine
n=138 Participants
Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
|
Escitalopram + Placebo
n=146 Participants
Participants will take escitalopram plus placebo.
Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks.
|
|---|---|---|---|
|
Quick Inventory of Depressive Symptoms
|
46.6 percentage of participants
5.6
|
41.8 percentage of participants
|
46.0 percentage of participants
5.4
|
SECONDARY outcome
Timeframe: Measured at Month 7The 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.
Outcome measures
| Measure |
Escitalopram + Bupropion SR
n=137 Participants
Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
|
Venlafaxine XR + Mirtazapine
n=138 Participants
Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
|
Escitalopram + Placebo
n=146 Participants
Participants will take escitalopram plus placebo.
Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks.
|
|---|---|---|---|
|
Quality of Life Inventory
|
0.6 units on a scale
Standard Deviation 2.1
|
0.4 units on a scale
Standard Deviation 2.4
|
0.4 units on a scale
Standard Deviation 2.6
|
Adverse Events
Escitalopram + Bupropion SR
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Venlafaxine XR + Mirtazapine
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Escitalopram + Placebo
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Escitalopram + Bupropion SR
n=221 participants at risk
Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
|
Venlafaxine XR + Mirtazapine
n=220 participants at risk
Participants will take Venlafaxine XR + Mirtazapine for up to 28 weeks.
|
Escitalopram + Placebo
n=224 participants at risk
Participants will take Escitalopram + Placebo for up to 28 weeks.
|
|---|---|---|---|
|
General disorders
Death, non-suicide
|
0.00%
0/221
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/220
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Cardiac disorders
Medial Hospitialization
|
0.90%
2/221 • Number of events 2
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
2.3%
5/220 • Number of events 5
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
2.2%
5/224 • Number of events 5
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Cardiac disorders
Medical Event, not requiring hospitalizaion
|
0.00%
0/221
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/220
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medical Event, not requiring hospitalization
|
0.00%
0/221
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/220
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Pregnancy, puerperium and perinatal conditions
Medical Event, not requiring hospitalization
|
0.45%
1/221 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/220
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/224
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Nervous system disorders
Medical Event, not requiring hospitalization
|
0.45%
1/221 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/220
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/224
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Surgical and medical procedures
Medical Hospitalization
|
0.45%
1/221 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.91%
2/220 • Number of events 2
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
General disorders
Medical Hospitalization
|
1.4%
3/221 • Number of events 3
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
1.4%
3/220 • Number of events 3
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
1.3%
3/224 • Number of events 3
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Nervous system disorders
Medical Hospitalization
|
1.4%
3/221 • Number of events 3
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
1.8%
4/220 • Number of events 4
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Respiratory, thoracic and mediastinal disorders
Medical Hospitalization
|
0.45%
1/221 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/220
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.89%
2/224 • Number of events 2
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Gastrointestinal disorders
Medical Hospitalization
|
0.45%
1/221 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.91%
2/220 • Number of events 2
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Psychiatric disorders
Psychiatric Event (non-hospitalized)
|
0.45%
1/221 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
1.4%
3/220 • Number of events 3
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.45%
1/224 • Number of events 1
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
|
Psychiatric disorders
Psychiatric Hospitalizaion
|
0.00%
0/221
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.91%
2/220 • Number of events 2
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
0.00%
0/224
All potential AEs collected using SAFTEE and FIBSER, but each AE final classification (SAE/OAE) was physicians' decision, and only SAEs were recorded for study. Hence, we are not able to provide complete AE numbers. Please note that all dosing and side effect information is published, and consistent with reported FDA findings and documentation.
|
Other adverse events
Adverse event data not reported
Additional Information
Madhukar H. Trivedi, M.D.
Univeristy of Texas Southwestern Medical Center, Dallas
Phone: 214-648-0188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place