A Phase 4 interventional study of Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro) and Placebo in Depression, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Treatment
This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.
We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 88 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For medication treatment, three different types were utilized and assigned specifically to each subject depending on their condition: MED 1: Venlafaxine XR. MED 2: Duloxetine (Cymbalta) MED 3: Escitalopram (Lexapro)
Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)
Subjects enrolled will receive interpersonal clinical interaction (ICI) along with a placebo treatment (Interaction and assessment as in ICI plus double blinded treatment with placebo tablets).
Other: Placebo
Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.
Behavioral: Interpersonal Clinical Interaction (ICI)
Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.
Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
Response as Assessed by Participants' Change in Depression Rating
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.
Time frame: Baseline, Week 8
Average Change in 3 Weeks of Participant Treatment Expectations
Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome.
Time frame: Averaged over 3 time points (Baseline, randomization, and end of lead-in)
Change in Hamilton Depression Assessment Score
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
Time frame: Baseline,Week 8
133 subjects were screened for eligibility and 88 were eligible for enrollment between 8/19/05 - 8/7/08 at the UCLA Laboratory of Brain, Behavior, and Pharmacology. 88 participants were randomized however, n=67 for many of the measures as subjects who did not complete the Week 8 visit were not included in the analysis.
| Milestone | MEDS + ICI | Placebo+ICI | ICI Alone |
|---|---|---|---|
| Started | 39 | 29 | 20 |
| Completed | 29 | 26 | 12 |
| Not completed | 10 | 3 | 8 |
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.
| Participants | MEDICATIONS | Placebo (PBO) | Interpersonal Clinical Interaction (ICI) |
|---|---|---|---|
| Responders | 17 | 11 | 1 |
| Remitters | 9 | 9 | 0 |
Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome.
| units on a scale | Medication (MED) | Placebo (PBO) | Interpersonal Clinical Interaction (ICI) |
|---|---|---|---|
| Average Change in 3 Weeks of Participant Treatment Expectations | 3.55 ± .78 | 3.94 ± .61 | 3.17 ± 1.16 |
Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.
| HAMD score | Medication (MED) | Placebo (PBO) | Interpersonal Clinical Interaction (ICI) |
|---|---|---|---|
| Percent Change in HAM-D | -0.46 ± 0.31 | -0.36 ± 0.39 | -0.05 ± 0.27 |
| Change in HAM-D | -10.05 ± 6.60 | -7.59 ± 7.98 | -1.37 ± 5.27 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medication | — | 0/39 (0%) | 0/29 (0%) |
| Placebo (PBO) | — | 0/29 (0%) | 0/26 (0%) |
| Interpersonal Clinical Interaction (ICI) | — | 0/20 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Medication Treatment (MED) | Placebo | Interpersonal Clinical Interaction | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 29 | 20 | 88 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Medication Treatment (MED) | Placebo | Interpersonal Clinical Interaction | Total |
|---|---|---|---|---|
| Mean | 41.67 ± 13.63 | 41.75 ± 14.35 | 43.1 ± 12.7 | 41.96 ± 13.74 |
| Sex: Female, Male(Participants) | Medication Treatment (MED) | Placebo | Interpersonal Clinical Interaction | Total |
|---|---|---|---|---|
| Female | 25 | 18 | 12 | 55 |
| Male | 14 | 11 | 8 | 33 |
| Region of Enrollment(participants) | Medication Treatment (MED) | Placebo | Interpersonal Clinical Interaction | Total |
|---|---|---|---|---|
| United States | 29 | 26 | 12 | 67 |
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles