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 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.

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Drug: Escitalopram + RT2CK17; Drug: Escitalopram + Placebo

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Escitalopram + RT2CK17; 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.
PLACEBO_COMPARATOR: 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.	Drug: Escitalopram + Placebo; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.

Publications and helpful links

General Publications

• Paulus MP, Kuplicki R, Victor TA, Yeh HW, Khalsa SS. Methylphenidate augmentation of escitalopram to enhance adherence to antidepressant treatment: a pilot randomized controlled trial. BMC Psychiatry. 2021 Nov 19;21(1):582. doi: 10.1186/s12888-021-03583-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): May 15, 2019
• Study Completion (ACTUAL): May 15, 2019

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (ACTUAL): January 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: 2017-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes