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临床试验/NCT05487885
NCT05487885已完成4 期

Anhedonia, Development, and Emotions: Phenotyping and Therapeutics (ADEPT) Study

Erika Forbes1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2022年7月22日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
123
试验地点
1
主要终点
Montgomery-Asberg Depression Rating Scale (MADRS) Score

研究概览

简要总结

The goal of the ADEPT Study is to understand anhedonia in young people and how it changes based on treatments targeting the brain circuit underlying it. Anhedonia is a challenging mental health symptom that involves difficulty with motivation to experience pleasant events. This study could help develop treatments for people whose depression does not improve with traditional treatments.

The ADEPT Study includes two phases. In Phase 1, participants are asked to go through a series of activities to measure anhedonia, including MRI scans, blood draws, behavioral tasks, clinical interviews, questionnaires, and app-based assessments of experiences and behaviors. Phase 2 involves therapeutic activities, such as transcranial magnetic stimulation (TMS), positive affect training, and, for some people, ketamine administration. If the participant qualifies and is interested, they may choose to do Phase 2 activities in addition to Phase 1.

详细描述

In this research study, the investigators are trying to understand and change anhedonia in young people with depression. Anhedonia is experienced by many people who have depression, and it involves difficulty with motivation, energy, and anticipation of pleasant events. People who experience anhedonia often have more severe depression, experience depression for longer periods of time, and don't easily get better with traditional treatments. The investigators want to understand anhedonia early in life in order to help young people develop along healthy pathways and avoid chronic illness. Anhedonia is related to function in the brain's reward circuit, inflammation in the body, and people's experiences and behaviors, and will measure all of these. The investigators also want to understand anhedonia by using treatments that could improve it. To do that, activities will be used that have been used to treat depression and target the brain's reward circuit, which is believed to be the source of anhedonia. Finally, anhedonia will be measured over approximately 1 year to see how it changes with time, development, or treatment-based experiences. Eventually, the findings of this study might be useful for treating depression and improving people's quality of life.

The study is looking for 300 young people (aged 15-25) who are currently experiencing depression to participate in our research study. In Phase 1 of our study, a series of activities will be conducted to understand the characteristics of anhedonia, including MRI scans, blood draws, behavioral tasks, clinical interviews, questionnaires, and measurement of real-life experiences and behavior using a phone app. This is called "phenotyping" because these characteristics are also called phenotypes.

The eligibility process for Phase 1 will include an interview with questions about the participant's mood, experiences, and behaviors. This interview will take approximately 2-3 hours. With permission, interviews will be video recorded to facilitate training and supervision of study staff. Participants will also be asked questions about health, including treatment history.

Study procedures include 4 visits over approximately 1 year. These may be broken into two sessions per visit for scheduling reasons. In addition, the study will include an ongoing smartphone app-based assessment of mood, experiences, and behavior.

Visit 1 consists of an MRI scan, questionnaires about thoughts, emotions, and experiences, tasks on a computer and a blood draw by a trained phlebotomist. Visits 2-4 consists of a second MRI scan, questionnaires, tasks on a computer, a blood draw by a trained phlebotomist, and an interview about mood, experiences, and behaviors.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Phase 1 (all participants)
  • Current DSM-5 depressive disorder
  • Severity ≥ 12 on MADRS
  • Moderate-severe anhedonia (75% of sample) or low anhedonia (25% of sample)
  • Phase 2 (for participants in TBS and ketamine phase, in addition to above)
  • ≥ 1 failed antidepressant trial (for qualification for Phase 2 of study and definition of non-response to TMS in order to be eligible for ketamine) = Treatment for at least 6 weeks with an antidepressant medication reaching recommended dosage for adults for at least 3 weeks of the treatment (e.g., 20 mg fluoxetine)

排除标准

  • Phase 1 (all participants)
  • Lifetime psychosis, bipolar disorder, or developmental disorder
  • Serious, unstable neurological disorder (e.g., seizure disorder)
  • Brain injury with loss of consciousness
  • Moderate-severe substance use disorder, past 6 mos.
  • MRI contraindications (e.g., metal in body)
  • Phase 2 (for participants in TBS and ketamine phase, in addition to above)
  • Serious, unstable respiratory or cardiovascular illness
  • Pre-TBS: Alcohol binge in past week or > 3 drinks/day in past 3 days
  • Pre-ketamine: use of MAOIs in past 2 weeks
  • Pregnancy
  • High blood pressure
  • Current illicit stimulant use
  • Lifetime recreational ketamine or PCP use

研究组 & 干预措施

TMS and PAT

Experimental

All open label with no randomization to placebo

干预措施: Continuous theta burst stimulation (cTBS) (Device)

TMS and PAT

Experimental

All open label with no randomization to placebo

干预措施: Positive Affect Training (Behavioral)

TMS and PAT, then Ketamine

Experimental

All open label with no randomization to placebo

干预措施: Continuous theta burst stimulation (cTBS) (Device)

TMS and PAT, then Ketamine

Experimental

All open label with no randomization to placebo

干预措施: Positive Affect Training (Behavioral)

TMS and PAT, then Ketamine

Experimental

All open label with no randomization to placebo

干预措施: Ketamine Injectable Solution (Drug)

结局指标

主要结局

Montgomery-Asberg Depression Rating Scale (MADRS) Score

时间窗: pre- to post-TMS (over 2 weeks) and pre- to post-ketamine (24 hours)

This clinician-rated scale captures depression severity on a scale of 0-60, with higher scores reflecting greater severity

次要结局

  • Snaith Hamilton Pleasure Scale (SHAPS) Score(pre- to post-TMS (over 2 weeks) and pre- to post-ketamine (24 hours))

研究者

发起方
Erika Forbes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Erika Forbes

Professor

University of Pittsburgh

研究点 (1)

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