Adherence to Antidepressant Treatment in Subjects With Depression

Depression Clinical Trial

Official title:

Adherence to Antidepressant Treatment in Subjects With Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03388164
• Other study ID #: 2017-007
• Status: Terminated
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: November 2020
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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