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Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression (EMBARC)

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ClinicalTrials.gov Identifier: NCT01407094
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Depression
Interventions Drug: Sertraline
Drug: Placebo
Drug: BupropionXL
Enrollment 296
Recruitment Details  
Pre-assignment Details Final enrollment Stage 1: 296 (146 SERT, 150 PBO). Individuals who responded to their Stage 1 treatment remained on that treatment in Stage 2. Individuals who did not respond to their Stage 1 treatment were switched to a different treatment in Stage 2.
Arm/Group Title Sertraline Placebo BupropionXL
Hide Arm/Group Description

SSRI monotherapy

Sertraline: 50-200mg/day

Placebo control

Placebo: 1-4 pills per day

BupropionXL

150-450 mg/day

Other names: WelbutrinXL

Period Title: Stage 1
Started 146 [1] 150 [2] 0 [3]
Completed 112 [4] 123 [5] 0
Not Completed 34 27 0
[1]
Stage 1 Sertraline (SERT): 34 exited
[2]
Stage 1 Placebo (PBO): 27 exited.
[3]
Bupropion (BUP) was used only in Stage 2 for non-responders to SERT.
[4]
One participant completed Stage 1 but did not continue to Stage 2.
[5]
Four participants completed Stage 1 but did not continue to Stage 2.
Period Title: Stage 2
Started 134 [1] 46 [2] 53 [3]
Completed 113 35 38
Not Completed 21 11 15
[1]
Stage 2 SERT includes Stage 1 SERT responders (n=61) and Stage 1 PBO non-responders (n=73).
[2]
Stage 2 PBO includes Stage 1 PBO responders (n=47); 1 early exit (n=46).
[3]
Stage 2 BUP includes Stage 1 SERT non-responders (n=54); 1 early exit (n=53).
Arm/Group Title Sertraline Placebo BupropionXL Total
Hide Arm/Group Description

SSRI monotherapy

Sertraline: 50-200mg/day

Placebo control

Placebo: 1-4 pills per day

BupropionXL

150-450mg/day

Total of all reporting groups
Overall Number of Baseline Participants 146 150 0 296
Hide Baseline Analysis Population Description
Stage 1 is made up of Treatment A (SERT) and Treatment B (PBO). Non-responders to Treatment A were switched in Stage 2 to BUP, and non-responders in Treatment B were switched to SERT. Between randomization and baseline, 3 participants didn't meet inclusion criteria, hence the discrepancy between official enrollment and baseline population numbers.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 150 participants 0 participants 296 participants
<=18 years
6
   4.1%
4
   2.7%
10
   3.4%
Between 18 and 65 years
139
  95.2%
145
  96.7%
284
  95.9%
>=65 years
1
   0.7%
1
   0.7%
2
   0.7%
[1]
Measure Analysis Population Description: Of the 299 participants who were randomized, 3 were randomized but did not meet criteria, resulting in 296 who were randomized and assessed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 150 participants 0 participants 296 participants
37.2  (13.8) 36.9  (12.8) 37.05  (13.3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 150 participants 0 participants 296 participants
Female
102
  69.9%
92
  61.3%
194
  65.5%
Male
44
  30.1%
58
  38.7%
102
  34.5%
[1]
Measure Analysis Population Description: Measure Analysis Population Description: Of the 299 participants who were randomized, 3 were randomized but did not meet criteria, resulting in 296 who were randomized and assessed
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 146 participants 150 participants 0 participants 296 participants
146 150 296
1.Primary Outcome
Title Hamilton Rating Scale for Depression
Hide Description

The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS)

  • Scores range from 0-52
  • Lower scores indicate less depressive symptomatology, and so are the more desirable.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Note subjects in the efficacy trial were those that completed 8 weeks of treatment, 115 in the sertraline group, and 123 in the placebo group. SERT had 34 wash-outs, PBO had 27.
Arm/Group Title Sertraline Placebo BupropionXL
Hide Arm/Group Description:

SSRI monotherapy

Sertraline: 50-200mg/day

Placebo control

Placebo: 1-4 pills per day

BupropionXL

150-450mg/day

Overall Number of Participants Analyzed 146 150 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.06  (6.71) 12.52  (7.68)
Time Frame 8 weeks for each Stage (1 and 2)
Adverse Event Reporting Description For both Serious and Other adverse events: SERT total is the sum of Stages 1 or 2, Treatment A plus Treatment D (210+73); PBO total is the sum of Stages 1 or 2, Treatment B (150+46). BUP was only used during Stage 2 (Treatment C).
 
Arm/Group Title Sertraline Placebo BupropionXL
Hide Arm/Group Description

SSRI monotherapy

Sertraline: 50-200mg/day

Placebo control

Placebo: 1-4 pills per day

BupropionXL

150-450 mg/day

All-Cause Mortality
Sertraline Placebo BupropionXL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline Placebo BupropionXL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/283 (3.53%)      7/196 (3.57%)      1/53 (1.89%)    
Cardiac disorders       
ER Visit * [1]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Endocrine disorders       
ER Visit * [2]  0/283 (0.00%)  0 1/196 (0.51%)  1 0/53 (0.00%)  0
Gastrointestinal disorders       
ER Visit * [3]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
General disorders       
ER Visit * [4]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
ER Visit * [5]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Nervous system disorders       
Seizure * [6]  0/283 (0.00%)  0 0/196 (0.00%)  0 1/53 (1.89%)  1
Psychiatric disorders       
Suicidality * [7]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Suicidality * [8]  0/283 (0.00%)  0 1/196 (0.51%)  1 0/53 (0.00%)  0
Suicidality * [9]  0/283 (0.00%)  0 1/196 (0.51%)  1 0/53 (0.00%)  0
Panic attack * [10]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Panic attack * [11]  0/283 (0.00%)  0 1/196 (0.51%)  1 0/53 (0.00%)  0
ER Visit * [12]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Suicidality * [13]  0/283 (0.00%)  0 1/196 (0.51%)  1 0/53 (0.00%)  0
Hospitalization  [14]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Reproductive system and breast disorders       
Pregnancy * [15]  0/283 (0.00%)  0 2/196 (1.02%)  2 0/53 (0.00%)  0
Pregnancy * [16]  1/283 (0.35%)  1 0/196 (0.00%)  0 0/53 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Chest pain with emergency hospitalization
[2]
Type-I Diabetes with brittle blood sugar control; hospital admin w/ ketoacidosis
[3]
ER visit with diagnosis of acute cholecystitis
[4]
ER visit with fever
[5]
Chest pain with emergency hospitalization; diagnosis of non-cardiac chest pain
[6]
Seizure
[7]
Emergent suicidality
[8]
Involuntary hospitalization for suicidality
[9]
Worsening depression, suicidal ideation
[10]
Panic attack, arrested
[11]
Panic attack
[12]
Worsening depression, suicidal ideation to ER
[13]
Hospitalization for suicidality
[14]
Worsening depression, suicidal ideation; psych hospitalization
[15]
Became pregnant
[16]
Exited study due to pregnancy on 9/16/12 and gave birth to microcephalic child on 5/7/13
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline Placebo BupropionXL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   233/283 (82.33%)      89/196 (45.41%)      27/53 (50.94%)    
Cardiac disorders       
Palpitations *  13/283 (4.59%)  13 3/196 (1.53%)  3 3/53 (5.66%)  3
Gastrointestinal disorders       
Diarrhea *  34/283 (12.01%)  34 11/196 (5.61%)  11 2/53 (3.77%)  2
General disorders       
Dizziness *  12/283 (4.24%)  12 6/196 (3.06%)  6 6/53 (11.32%)  6
Fatigue *  13/283 (4.59%)  13 2/196 (1.02%)  2 1/53 (1.89%)  1
Dry Mouth *  33/283 (11.66%)  33 8/196 (4.08%)  8 0/53 (0.00%)  0
Headaches *  41/283 (14.49%)  41 46/196 (23.47%)  46 9/53 (16.98%)  9
Insomnia *  30/283 (10.60%)  30 3/196 (1.53%)  3 1/53 (1.89%)  1
Nausea *  57/283 (20.14%)  57 10/196 (5.10%)  10 5/53 (9.43%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Madhukar H. Trivedi
Organization: University of Texas Southwestern Medical Center
Phone: 214-648-0188
EMail: madhukar.trivedi@UTSouthwestern.edu
Publications:
Layout table for additonal information
Responsible Party: Madhukar H. Trivedi, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01407094     History of Changes
Other Study ID Numbers: STU 092010-151
First Submitted: July 25, 2011
First Posted: August 1, 2011
Results First Submitted: July 19, 2018
Results First Posted: December 25, 2018
Last Update Posted: December 25, 2018