Adherence to Antidepressant Treatment in Subjects With Depression
Primary Purpose
Depression
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram + RT2CK17
Escitalopram + Placebo
Sponsored by
About this trial
This is an interventional other trial for Depression
Eligibility 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
Sites / Locations
- Laureate Institute for Brain Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Escitalopram + RT2CK17
Escitalopram + Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03388164
First Posted
December 22, 2017
Last Updated
August 19, 2021
Sponsor
Laureate Institute for Brain Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03388164
Brief Title
Adherence to Antidepressant Treatment in Subjects With Depression
Official Title
Adherence to Antidepressant Treatment in Subjects With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram + RT2CK17
Arm Type
Active Comparator
Arm 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.
Arm Title
Escitalopram + Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Escitalopram + RT2CK17
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Escitalopram + Placebo
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin P Paulus, M.D.
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Study Director
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34798853
Citation
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.
Results Reference
derived
Learn more about this trial
Adherence to Antidepressant Treatment in Subjects With Depression
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