Adherence to Antidepressant Treatment in Subjects With Depression

• Sponsor: Laureate Institute for Brain Research, Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03388164
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Escitalopram + RT2CK17; Drug: Escitalopram + Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Adherence to Antidepressant Treatment in Subjects With Depression
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: May 15, 2019
• Actual Study Completion Date: May 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rate of Adherence [8 weeks]

   To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count

Secondary Outcome Measures

1. Adherence Consistency [8 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laureate Institute for Brain Research	Tulsa	Oklahoma	United States	74136

Sponsors and Collaborators

• Laureate Institute for Brain Research, Inc.

Investigators

• Study Director: Martin P Paulus, M.D., Laureate Institute for Brain Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 7, 2017
• Informed Consent Form - Nov 30, 2017

More Information

Publications

None provided.

• Responsible Party: Laureate Institute for Brain Research, Inc.
• ClinicalTrials.gov Identifier: NCT03388164
• Other Study ID Numbers: 2017-007
• First Posted: Jan 2, 2018
• Last Update Posted: Sep 16, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Depression; Depressive Disorder; Dexetimide; Citalopram

Study Results

Participant Flow

Pre-assignment Detail	Three individuals were excluded prior to group assignment: 2- did not meet inclusion criteria (alcohol use, low TSH) 1- declined to participate

Arm/Group Title	Escitalopram + RT2CK17	Escitalopram + Placebo
Arm/Group Description	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. 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.	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. 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.
Period Title: Overall Study
STARTED	10	10
COMPLETED	7	9
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Escitalopram + RT2CK17	Escitalopram + Placebo	Total
Arm/Group Description	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.5 (10.7)	31.0 (10.6)	31.3 (10.4)
Sex: Female, Male (Count of Participants)
Female	7 70%	8 80%	15 75%
Male	3 30%	2 20%	5 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 10%	1 10%	2 10%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	8 80%	9 90%	17 85%
More than one race	1 10%	0 0%	1 5%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram + RT2CK17	Escitalopram + Placebo
Arm/Group Description	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. 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.	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. 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.
Measure Participants	7	9
Mean (Standard Deviation) [percentage of pills taken]	93.5 (7.6)	97.6 (6.5)

2. Secondary Outcome

Title	Adherence Consistency
Description	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
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram + RT2CK17	Escitalopram + Placebo
Arm/Group Description	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. 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.	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. 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.
Measure Participants	7	9
Mean (Standard Deviation) [percentage of pills taken on time]	89.8 (8.2)	93.6 (8.4)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Escitalopram + RT2CK17		Escitalopram + Placebo
Arm/Group Description	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. 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.		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. 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.
All Cause Mortality
	Escitalopram + RT2CK17		Escitalopram + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Escitalopram + RT2CK17		Escitalopram + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Escitalopram + RT2CK17		Escitalopram + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.