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临床试验/NCT03388164
NCT03388164终止2 期

Adherence to Antidepressant Treatment in Subjects With Depression

Laureate Institute for Brain Research, Inc.1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
23
试验地点
1
主要终点
Rate of Adherence

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Baseline QIDS-SR ≥ 14 (moderate depression)
  • Age 18 - 65
  • Written Informed Consent
  • Major Depressive Disorder, single-episode/recurrent, not in remission

排除标准

  • RT2CK17-related exclusions
  • Uncontrolled hyperthyroidism
  • 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

研究组 & 干预措施

Escitalopram + RT2CK17

Active Comparator

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.

干预措施: Escitalopram + RT2CK17 (Drug)

Escitalopram + Placebo

Placebo Comparator

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.

干预措施: Escitalopram + Placebo (Drug)

结局指标

主要结局

Rate of Adherence

时间窗: 8 weeks

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

次要结局

  • Adherence Consistency(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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