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Anhedonia Therapies for Depression (ADEPT Trial)

Phase 4

Recruiting

Led By Erika E Forbes, PhD

Research Sponsored by Erika Forbes

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current DSM-5 depressive disorder

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre- to post-tms (over 2 weeks)

Awards & highlights

ADEPT Trial Summary

This trial is studying anhedonia and how to treat it in young people by targeting the brain circuit underlying it. Anhedonia is a symptom of mental health that makes it difficult to experience pleasant events. This study could help develop treatments for people whose depression does not improve with traditional treatments.

Who is the study for?

This trial is for young people with depression and anhedonia, who have not improved after at least one antidepressant treatment. Participants must show moderate to severe symptoms of anhedonia and a certain level of depression severity. They cannot join if they've had brain injuries causing unconsciousness, use daily nicotine or certain medications, have metal in their body, are pregnant, or have specific psychiatric or neurological conditions.Check my eligibility

What is being tested?

The ADEPT Study aims to understand and treat anhedonia by using MRI scans, blood tests, interviews, and app-based assessments (Phase 1). In Phase 2, treatments like transcranial magnetic stimulation (TMS), positive affect training exercises, and ketamine injections are tested for therapeutic effects on the brain circuits associated with pleasure and motivation.See study design

What are the potential side effects?

Possible side effects include discomfort from TMS such as scalp pain or headache; emotional changes due to positive affect training; and ketamine-related effects like dissociation (feeling detached from reality), nausea, increased heart rate/blood pressure during infusion.

ADEPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with depression.

ADEPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre- to post-tms (over 2 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre- to post-tms (over 2 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- to post-tms (over 2 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Montgomery-Asberg Depression Rating Scale (MADRS) score

Secondary outcome measures

Snaith Hamilton Pleasure Scale (SHAPS) score

ADEPT Trial Design

2Treatment groups

Experimental Treatment

Group I: TMS and PAT, then KetamineExperimental Treatment3 Interventions

All open label with no randomization to placebo

Group II: TMS and PATExperimental Treatment2 Interventions

All open label with no randomization to placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine Injectable Solution

2018

Completed Phase 1

~60

Continuous theta burst stimulation (cTBS)

2020

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Erika ForbesLead Sponsor

2 Previous Clinical Trials

59 Total Patients Enrolled

Erika E Forbes, PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Ketamine Injectable Solution Clinical Trial Eligibility Overview. Trial Name: NCT05487885 — Phase 4

Anhedonia Clinical Trial 2023: Ketamine Injectable Solution Highlights & Side Effects. Trial Name: NCT05487885 — Phase 4

Ketamine Injectable Solution 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487885 — Phase 4

Anhedonia Research Study Groups: TMS and PAT, then Ketamine, TMS and PAT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 45 and over eligible to join this research?

"The eligibility criteria for this medical trial includes individuals aged 15-25."

Answered by AI

Has the FDA approved Ketamine Injectable Solution for use?

"Our group at Power judged ketamine injectable solution to have a score of 3 due to being in the fourth phase of clinical trials and thus, approved for usage."

Answered by AI

What is the aggregate participation rate of this clinical experiment?

"Affirmative. According to information posted on clinicaltrials.gov, the trial opened for recruitment on July 22nd 2022 and was most recently updated August 3rd 2022. The project is seeking 275 participants from a single medical facility."

Answered by AI

Are researchers presently recruiting test subjects for this experiment?

"Affirmative. Clinicaltrials.gov is hosting evidence that this experiment, which was made available on July 22nd 2022, is currently recruiting participants. The study necessitates the recruitment of 275 individuals from a single centre."

Answered by AI

Am I eligible to participate in this investigation?

"This clinical study is seeking 275 individuals, ranging from 15 to 25 years old and diagnosed with depression. The inclusion criteria are fairly extensive: Phase 1 (all participants) must have a DSM-5 depressive disorder of severity 12 or higher on MADRS; 75% of the sample must display moderate-severe anhedonia while 25% must demonstrate low anhedonia. Furthermore for those being considered for TBS and ketamine in Phase 2, it is necessary that they have experienced at least one unsuccessful antidepressant treatment lasting 6 weeks at the recommended adult dosage (e.g., 20 mg fluoxetine)."

Answered by AI