Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03388164 · ClinicalTrials.gov registry record · Phase 2
Adherence to Antidepressant Treatment in Subjects With Depression
A Phase 2 study, sponsored by Laureate Institute for Brain Research.
- Terminated
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT03388164 is a Phase 2 study that was terminated before completion, run by Laureate Institute for Brain Research. The registered enrollment target is 23 participants.
The verdict
NCT03388164, a Phase 2 study, was terminated before completion, sponsored by Laureate Institute for Brain Research.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Escitalopram + Placebo
- DRUG Escitalopram + RT2CK17
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-01-01 |
| Est. Completion | 2019-05-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03388164
The ClinicalTrials.gov registry entry for NCT03388164 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laureate Institute for Brain Research, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Escitalopram + Placebo is the first listed.
NCT03388164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03388164 about?
NCT03388164 is a clinical study titled "Adherence to Antidepressant Treatment in Subjects With Depression". 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 randomi...
What is the current status of trial NCT03388164?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-01-01. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT03388164?
The interventions under investigation include: Escitalopram + Placebo (DRUG), Escitalopram + RT2CK17 (DRUG).
Who is sponsoring clinical trial NCT03388164?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.