Adherence to Antidepressant Treatment in Subjects With Depression
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
- 否
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
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
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)
