A Phase 3 interventional study of escitalopram and placebo in Opiate Dependence and Depression, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-03.
Sponsored by Butler Hospital · Phase 3, Interventional, and Treatment
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 147 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: placebo
Drug: escitalopram
10mg escitalopram/day for 3 months
placebo capsule/day for 3 months
Percentage of Participants Who Dropped Out of Buprenorphine Treatment
Drop-out is defined as 7 or more days of missed Buprenorphine doses
Time frame: 3 months
Depressive Symptoms
Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.
Time frame: 3 months
| Milestone | Placebo | 10 mg Escitalopram |
|---|---|---|
| Started | 75 | 72 |
| Completed | 75 | 72 |
| Not completed | 0 | 0 |
Drop-out is defined as 7 or more days of missed Buprenorphine doses
| percentage of participants | 10 mg Escitalopram | Placebo |
|---|---|---|
| Percentage of Participants Who Dropped Out of Buprenorphine Treatment | 33.3 | 44.0 |
Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.
| units on a scale | 10 mg Escitalopram | Placebo |
|---|---|---|
| Depressive Symptoms | 12.31 ± 1.79 | 11.35 ± 1.46 |
Collected over adverse event information was collected at each study appointment, which occurred every 1-2 weeks throughout participant's 12-week study participation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/75 (1.3%) | 0/75 (0%) |
| 10 mg Escitalopram | — | 0/72 (0%) | 0/72 (0%) |
| Event | Placebo | 10 mg Escitalopram |
|---|---|---|
| increasing clinical symptomsPsychiatric disorders | 1/75 | 0/72 |
| Age, Categorical(Participants) | Placebo | 10 mg Escitalopram | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 75 | 72 | 147 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Placebo | 10 mg Escitalopram | Total |
|---|---|---|---|
| Mean | 36.8 ± 9.8 | 38.3 ± 9.6 | 37.5 ± 9.9 |
| Sex: Female, Male(Participants) | Placebo | 10 mg Escitalopram | Total |
|---|---|---|---|
| Female | 18 | 17 | 35 |
| Male | 57 | 55 | 112 |
| Region of Enrollment(participants) | Placebo | 10 mg Escitalopram | Total |
|---|---|---|---|
| United States | 75 | 72 | 147 |
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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