Adherence to Antidepressant Treatment in Subjects With Depression

NCT03388164 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2017-007
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adherence Consistency

  8 weeks

Study Arms (2)

Escitalopram + RT2CK17

ACTIVE COMPARATOR

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

Escitalopram + Placebo

PLACEBO COMPARATOR

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

Interventions

Escitalopram + RT2CK17 DRUG

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.

Escitalopram + RT2CK17

Escitalopram + Placebo DRUG

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.

Escitalopram + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (1)

• 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.

  PMID: 34798853 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated early based on the planned interim analysis.

Results Point of Contact

• Title: Teresa Victor
• Organization: Laureate Institute for Brain Research

tvictor@laureateinstitute.org

918-502-5108

Study Officials

• Martin P Paulus, M.D.

  Laureate Institute for Brain Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: January 1, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)