Adherence to Antidepressant Treatment in Subjects With Depression

Study Overview
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Brief Summary
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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.

Official Title
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Adherence to Antidepressant Treatment in Subjects With Depression

Conditions
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Depression

Intervention / Treatment
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* Drug: Escitalopram + RT2CK17
* Drug: Escitalopram + Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escitalopram + RT2CK17<br>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. | Drug: Escitalopram + RT2CK17<br>* Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.<br>|
| Placebo Comparator: Escitalopram + Placebo<br>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. | Drug: Escitalopram + Placebo<br>* Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adherence | To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence Consistency | 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 | 8 weeks |