Adherence to Antidepressant Treatment in Subjects With Depression

Phase 2

Terminated

• Conditions: Depression
• Interventions: Drug: Escitalopram + RT2CK17; Drug: Escitalopram + Placebo

• Registration Number: NCT03388164
• Lead Sponsor: Laureate Institute for Brain Research, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study Start: 2018-01-01
• Study First Posted: 2018-01-02
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2020-11
• Results First Submitted: 2020-11-17
• Results First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Results First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Baseline QIDS-SR ≥ 14 (moderate depression)
• Age 18 - 65
• Written Informed Consent
• Major Depressive Disorder, single-episode/recurrent, not in remission

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram + RT2CK17	Escitalopram + RT2CK17	10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.
Escitalopram + Placebo	Escitalopram + Placebo	10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.

Primary Outcome Measures

Name	Time	Method
Rate of Adherence	8 weeks	To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count

Secondary Outcome Measures

Name	Time	Method
Adherence Consistency	8 weeks	To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time

Trial Locations

Locations (1)

Laureate Institute for Brain Research; 🇺🇸 Tulsa, Oklahoma, United States