Adherence to Antidepressant Treatment in Subjects With Depression

• Status: Terminated
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laureate Institute for Brain Research, Inc.
• Treatments: Citalopram; Dexetimide

Criteria

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