Psilocybin - 주요 우울 장애 치료에서 유도된 신경가소성
The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.
연구 개요
상태
정황
상세 설명
In this placebo-controlled, blinded study, individuals with depression will participate in 2 experimental sessions approximately 4 weeks apart during which they will receive two of the following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium dose psilocybin (0.3 mg/kg).
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 장소
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Connecticut
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West Haven, Connecticut, 미국, 06516
- VA Connecticut Healthcare System, West Haven Campus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE)
- Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode
- Currently engaged in treatment with a mental health clinician
Exclusion Criteria:
- Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- Axis I psychotic disorder in first degree relative
- Currently taking a conventional antidepressant medication
- Unstable medical or neurological conditions
- Significant cognitive disorders
- History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc.
- Pregnant, breastfeeding, lack of adequate birth control
- Urine toxicology positive to drugs of abuse on experimental test days
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session. |
0.1 mg/kg psilocybin capsule microcrystalline cellulose capsule |
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실험적: Placebo/Medium Dose Psilocybin
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session. |
microcrystalline cellulose capsule 0.3 mg/kg psilocybin capsule |
|
실험적: Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session. |
0.1 mg/kg psilocybin capsule microcrystalline cellulose capsule |
|
실험적: Medium Dose Psilocybin/Placebo
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session. |
microcrystalline cellulose capsule 0.3 mg/kg psilocybin capsule |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
기간: One day and two weeks after each experimental session
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An auditory Long Term Potentiation (LTP) task will assess changes in neuroplasticity. For the EEG task, the outcome measures will include stimulus-evoked time x frequency analysis (e.g., spectral power) |
One day and two weeks after each experimental session
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]
기간: One day and two weeks after each experimental session
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This will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT), administered while EEG data is collected. The EEG outcomes will include time x frequency analysis (e.g., spectral power) during the learning and recognition phases of the task. |
One day and two weeks after each experimental session
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Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
기간: Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
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The GRID-Hamilton Depression Rating Scale is a clinician-administered rating scale designed to assess severity of depressive symptoms. It includes 17 items, nine of which are scored on 5-point scale, and eight of which are scored on a three-point scale. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. |
Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
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Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)
기간: Four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
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The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms. |
Four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000022394
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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