Adherence to Antidepressant Treatment in Subjects With Depression

Laureate Institute for Brain Research (LIBR)

Status and phase: Terminated; Phase 2

Conditions: Depression

Treatments: Drug: Escitalopram + Placebo; Drug: Escitalopram + RT2CK17

Study type: Interventional

Funder types: Other

Identifiers

NCT03388164

2017-007

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

Escitalopram + RT2CK17

Active Comparator 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.

Treatment:

Drug: Escitalopram + RT2CK17

Escitalopram + Placebo

Placebo Comparator group

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.

Treatment:

Drug: Escitalopram + Placebo