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 |
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.
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
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