Anhedonia Therapies for Depression
(ADEPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore new treatments for young people dealing with anhedonia, a symptom of depression characterized by difficulty in feeling pleasure or motivation. It tests various therapies, such as brain stimulation—including Continuous Theta Burst Stimulation, a variant of transcranial magnetic stimulation—and positive affect training. Ketamine may be included for those who haven't improved with other antidepressants. Individuals experiencing depression and struggling to enjoy daily activities might be a good fit for this trial. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing an opportunity to assess their benefits for more patients.
Will I have to stop taking my current medications?
The trial requires that participants stop taking certain medications, such as SNRIs, bupropion, antipsychotics, or stimulants, before participating in Phase 2 activities like TMS and ketamine administration.
What is the safety track record for these treatments?
Research has shown that continuous theta burst stimulation (cTBS) is generally safe. The FDA has approved cTBS, a type of brain stimulation, for treating depression. It uses short bursts of magnetic pulses. Studies have found that cTBS can be as effective as other brain stimulation methods, with similar safety levels. Side effects are usually mild and may include headaches or scalp discomfort.
Ketamine, when administered as an injection for depression, is also well-tolerated. Research suggests that low-dose ketamine works quickly to relieve depression symptoms. Common side effects might include dizziness or feeling unusual, but these effects usually don't last long.
Positive Affect Training focuses on increasing positive feelings and experiences. Research has shown it can help reduce symptoms of depression and anxiety. Studies report no significant safety concerns, making it a safe option for many people.
In summary, all these treatments have promising safety records. They are generally well-tolerated with mild, short-lived side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for depression because they offer innovative approaches beyond traditional antidepressants and therapies. Continuous theta burst stimulation (cTBS) is a form of transcranial magnetic stimulation that targets the brain's neural circuits more precisely and rapidly, potentially providing faster relief. Ketamine, known for its rapid-acting antidepressant effects, works differently than most treatments by modulating glutamate, a neurotransmitter linked to mood regulation, offering hope for those who don't respond to other medications. Positive Affect Training (PAT) aims to enhance emotional well-being through cognitive exercises, which could complement other treatments by building resilience and positive emotions. Each of these treatments provides a unique mechanism of action or method of delivery, setting them apart from current options like SSRIs or cognitive-behavioral therapy.
What evidence suggests that this trial's treatments could be effective for anhedonia in depression?
Research has shown that continuous theta burst stimulation (cTBS), a treatment in this trial, can reduce depression symptoms. Studies have found that cTBS can have lasting effects on brain activity, potentially improving mood. Ketamine, another treatment option in this trial, has shown promise for depression, with evidence suggesting it can quickly ease severe symptoms and even lead to recovery for some individuals. Positive Affect Training (PAT), also under study in this trial, focuses on boosting positive emotions and has been found to reduce depression and improve quality of life. Each of these treatments may help address anhedonia, the lack of pleasure or interest in activities, which is part of depression.56789
Who Is on the Research Team?
Erika E Forbes, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phenotyping
Participants undergo activities to measure anhedonia, including MRI scans, blood draws, behavioral tasks, clinical interviews, questionnaires, and app-based assessments
Therapeutic Activities
Participants receive therapeutic interventions such as transcranial magnetic stimulation (TMS), Positive Affect Training, and potentially ketamine administration
Follow-up
Participants are monitored for changes in anhedonia and depression severity over time
What Are the Treatments Tested in This Trial?
Interventions
- Continuous theta burst stimulation (cTBS)
- Ketamine Injectable Solution
- Positive Affect Training
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erika Forbes
Lead Sponsor