An interventional study of Escitalopram and Duloxetine in Depression, sponsored by Emory University. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-30.
Sponsored by Emory University · Not applicable, Interventional, and Treatment
This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.
Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Antidepressant medications and psychotherapy are among the effective treatments for MDD. Individuals often respond to one type of treatment, but not another. Currently, however, doctors have no way of pre-determining which individuals will most benefit from which treatments. In the absence of practical predictors of MDD treatment response, the potential efficacy of existing MDD treatments is limited. This study will identify factors that may predict MDD treatment response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in people with MDD.
Participants in this 14-week, double-blind study will be randomly assigned to receive duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2 weeks of screening, participants will complete questionnaires, clinician evaluations, an electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion of screening, patients will start the treatment to which they were randomized. Duloxetine and escitalopram are two medications that are approved by the Food and Drug Administration for the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also used to treat depression. All participants assigned to take duloxetine or escitalopram will be seen by a study physician weekly for 6 weeks, and then every other week for the remainder of the study. Participants assigned to cognitive behavioral therapy will attend therapy sessions twice a week for the first 4 weeks, and then once a week for the remainder of the study. The following assessments will be performed for all participants at each visit: vital sign and weight measurements; clinician assessments; and self-report questionnaires. Additionally, blood samples will be taken at three visits through the trial and functional magnetic resonance imaging (fMRI) scans will be performed at selected times.
A companion study to the main CIDAR study offers participants further treatment. Participants who achieve remission after the initial 12 weeks of treatment will have the option to enroll in a 21-month follow-up study of maintenance treatment, with visits every three months to monitor for sustained response and relapse. Participants who do not remit will have the option to enroll in another 12-week treatment course, receiving a combination of CBT and medication. Participants who achieve response after this combination treatment will be eligible to receive maintenance combination treatment for up to an additional 18 months, monitored for sustained response and relapse. Participants who do not wish to enroll or continue in the companion study will be provided with a referral for treatment with another mental health provider.
8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 344 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive treatment with escitalopram for 12 weeks
Drug: Escitalopram
Participants will receive treatment with duloxetine for 12 weeks
Drug: Duloxetine
Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks
Behavioral: Cognitive behavioral therapy (CBT)
Escitalopram 10 to 20 mg per day for 12 weeks
Also known as: Lexapro
Duloxetine 30 to 60 mg per day for 12 weeks
Also known as: Cymbalta
CBT will include 16 one-hour sessions provided over 12 weeks.
Remission From Major Depressive Episode in Intent to Treat Sample
The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.
Time frame: Up to 12 Weeks
Remission From Major Depressive Episode Among Participants Who Completed the Intervention
The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.
Time frame: Measured at Weeks 10 and 12
Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation: 1. Non-response: \<30% reduction from baseline 2. Partial Response: 30-49% reduction from baseline 3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score \>7 4. Remission: HDRS score ≤7
Time frame: Up to 12 Weeks
Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits: 1. Non-response: \<30% reduction from baseline 2. Partial Response: 30-49% reduction from baseline 3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score \>7 4. Remission: HDRS score ≤7
Time frame: Measured at Weeks 10 and 12
Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.
Time frame: Measured at 6, 9, 12, 15, 18, 21, and 24 months
Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy
The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks
Time frame: Measured after 12 weeks of combined treatment
Participants were recruited through the Emory University Mood and Anxiety Disorders Program. Men and women, aged 18-65, meeting DSM-IV criteria for a current major depressive disorder, and who had not received prior treatment for a mood disorder were eligible. 515 consented to participate in the trial and 344 were randomized to a treatment arm.
| Milestone | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Started | 114 | 115 | 115 |
| Had post-randomization assessment | 105 | 106 | 105 |
| Completed | 86 | 79 | 69 |
| Not completed | 28 | 36 | 46 |
The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.
| percentage of participants | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Remission From Major Depressive Episode in Intent to Treat Sample | 46.7 | 54.7 | 41.9 |
The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.
| percentage of participants | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Remission From Major Depressive Episode Among Participants Who Completed the Intervention | 44.2 | 51.9 | 43.5 |
Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation: 1. Non-response: \<30% reduction from baseline 2. Partial Response: 30-49% reduction from baseline 3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score \>7 4. Remission: HDRS score ≤7
| participants | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Non-Response | 26 | 21 | 32 |
| Partial Response | 12 | 16 | 19 |
| Response without remission | 18 | 11 | 10 |
| Remission | 49 | 58 | 44 |
Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits: 1. Non-response: \<30% reduction from baseline 2. Partial Response: 30-49% reduction from baseline 3. Response without remission: ≥50% reduction from baseline, but HDRS-17 score \>7 4. Remission: HDRS score ≤7
| participants | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Non-Response | 15 | 10 | 15 |
| Partial Response | 10 | 12 | 13 |
| Response without remission | 23 | 16 | 11 |
| Remission | 38 | 41 | 30 |
The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.
| participants | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| 6 Months | 0 | 0 | 1 |
| 9 Months | 1 | 2 | 1 |
| 12 Months | 1 | 2 | 3 |
| 15 Months | 1 | 4 | 5 |
| 18 Months | 2 | 4 | 5 |
| 21 Months | 3 | 5 | 5 |
| 24 Months | 3 | 5 | 5 |
The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks
| participants | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy | 22 | 10 | 18 |
Collected over Adverse events will be collected during the entire time a participant remains in the trial (up to 24 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Escitalopram | — | 6/114 (5.3%) | 100/114 (87.7%) |
| Duloxetine | — | 3/115 (2.6%) | 108/115 (93.9%) |
| Cognitive Behavioral Therapy (CBT) | — | 1/115 (0.9%) | 70/115 (60.9%) |
| Event | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| Motor Vehicle AccidentGeneral disorders | 2/114 | 1/115 | 0/115 |
| AttemptedSuicide by OverdosePsychiatric disorders | 0/114 | 2/115 | 0/115 |
| LacerationSkin and subcutaneous tissue disorders | 1/114 | 0/115 | 0/115 |
| Urinary retentionRenal and urinary disorders | 1/114 | 0/115 | 0/115 |
| Deep vein thrombosisVascular disorders | 1/114 | 0/115 | 0/115 |
| Lung cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/114 | 0/115 | 0/115 |
| Hospitalization for asthma attackRespiratory, thoracic and mediastinal disorders | 0/114 | 0/115 | 1/115 |
| Event | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) |
|---|---|---|---|
| HeadacheGeneral disorders | 36/114 | 38/115 | 19/115 |
| NauseaGastrointestinal disorders | 29/114 | 37/115 | 8/115 |
| Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 14/114 | 31/115 | 27/115 |
| Dry MouthGeneral disorders | 18/114 | 28/115 | 2/115 |
| FatigueGeneral disorders | 22/114 | 27/115 | 2/115 |
| InsomniaGeneral disorders | 20/114 | 26/115 | 3/115 |
| DiarrheaGastrointestinal disorders | 23/114 | 22/115 | 11/115 |
| DizzinessGeneral disorders | 16/114 | 21/115 | 4/115 |
| SedationGeneral disorders | 15/114 | 18/115 | 4/115 |
| Abdominal PainGastrointestinal disorders | 7/114 | 13/115 | 7/115 |
Participants who consented to participate in the trial and who were randomized to a treatment arm.
| Age, Categorical(Participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 114 | 115 | 115 | 344 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| Mean | 41.6 ± 12.1 | 38.3 ± 11.4 | 40.0 ± 11.3 | 40.0 ± 11.7 |
| Sex: Female, Male(Participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| Female | 64 | 68 | 64 | 196 |
| Male | 50 | 47 | 51 | 148 |
| Ethnicity (NIH/OMB)(Participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 36 | 34 | 32 | 102 |
| Not Hispanic or Latino | 78 | 81 | 83 | 242 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 28 | 23 | 13 | 64 |
| White | 47 | 56 | 61 | 164 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 39 | 36 | 41 | 116 |
| Region of Enrollment(participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| United States | 114 | 115 | 115 | 344 |
| Current Anxiety Disorder(participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| Yes | 67 | 67 | 71 | 205 |
| No | 47 | 48 | 44 | 139 |
| Previous Episode(s) of Depression(participants) | Escitalopram | Duloxetine | Cognitive Behavioral Therapy (CBT) | Total |
|---|---|---|---|---|
| One | 59 | 51 | 67 | 177 |
| Two | 20 | 26 | 17 | 63 |
| Three or more | 33 | 38 | 28 | 99 |
| None | 2 | 0 | 3 | 5 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Emory University