Adherence to Antidepressant Treatment in Subjects With Depression
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Depression
In brief
This study aims to determine whether a combination a first-line antidepressant plus "RT2CK17" in a capsule relative to a first-line antidepressant plus placebo in a capsule results in higher rates of medication adherence in individuals with moderate to severe depression. In this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to receive 5 milligrams (mg) "RT2CK17" + 10 mg escitalopram or placebo + 10 mg escitalopram to be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to test our hypotheses.
Key facts
- Study ID
- NCT03388164
- Run by
- Laureate Institute for Brain Research, Inc.
- People needed
- 23
- Starts
- 2018-01-01
- Expected to finish
- 2019-05-15
- Last updated by the study team
- 2021-09-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Baseline QIDS-SR ≥ 14 (moderate depression)
- Age 18 - 65
- Written Informed Consent
- Major Depressive Disorder, single-episode/recurrent, not in remission
You may not qualify if…
- RT2CK17-related exclusions
- Uncontrolled hyperthyroidism
- Glaucoma
- Motor tics
- Monoamine oxidase inhibitor treatment
- Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias
- Uncontrolled hypertension
- Peripheral vasculopathy
- Pregnancy
- Bipolar Disorder
- Psychotic Disorder
- History of intolerability of study medications
- Currently taking psychiatric medications
- Current Substance Use Disorder (other than nicotine)
- Current Alcohol Use Disorder
Where it is running
- Laureate Institute for Brain Research — Tulsa, Oklahoma, United States
Full record on ClinicalTrials.gov
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