Ketamine Injectable Solution for Depression
Phase-Based Progress Estimates
Effectiveness
Safety
Loeffler Building, Pittsburgh, PA
Depression+1 More
Ketamine Injectable Solution - DrugEligibility
< 65
All Sexes
What conditions do you have?
Select
Eligibility
< 65
All Sexes
What conditions do you have?
Select
Study Summary
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.
Eligible Conditions
- Depression
- Anhedonia
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: change from Baseline to 12 months post-ketamine
Month 12
Montgomery-Asberg Depression Rating Scale (MADRS) change in score
Snaith Hamilton Pleasure Scale (SHAPS) score
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
TMS and PAT, then Ketamine
1 of 2
TMS and PAT
1 of 2
Experimental Treatment
275 Total Participants · 2 Treatment Groups
Primary Treatment: Ketamine Injectable Solution · No Placebo Group · Phase 4
TMS and PAT, then KetamineExperimental Group · 3 Interventions: Continuous theta burst stimulation (cTBS), Positive Affect Training, Ketamine Injectable Solution · Intervention Types: Device, Behavioral, Drug
TMS and PATExperimental Group · 2 Interventions: Continuous theta burst stimulation (cTBS), Positive Affect Training · Intervention Types: Device, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous theta burst stimulation (cTBS)
2020
N/A
~30
Ketamine Injectable Solution
2018
Completed Phase 1
~60
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 12 months post-ketamine
Closest Location: Loeffler Building · Pittsburgh, PA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Depression
0 CompletedClinical Trials
Who is running the clinical trial?
Erika ForbesLead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
2 Trials studying Depression
59 Patients Enrolled for Depression
Erika E Forbes, PhDPrincipal InvestigatorUniversity of Pittsburgh
Eligibility Criteria
Age < 65 · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have moderate-severe anhedonia or low anhedonia.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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