Adherence to Antidepressant Treatment in Subjects With Depression



Status:Active, not recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:1/31/2019
Start Date:January 1, 2018
End Date:January 1, 2021

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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.


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
We found this trial at
1
site
Tulsa, Oklahoma 74136
Phone: 918-502-5108
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mi
from
Tulsa, OK
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