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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: Clinical Trial Phase 2 study, sponsored by Laureate Institute for Brain Research.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count
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 |
Why NCT03388164 stopped before completion
NCT03388164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Escitalopram + Placebo is the first listed.
NCT03388164 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03388164's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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