Apimostinel + Cognitive Training for Depression

Phase 2

Recruiting

Led By Rebecca B Price, PhD

Research Sponsored by Rebecca Price

Eligibility Criteria Checklist

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

Must have

Participants of any gender aged 18 to 60 years

Have not responded to one or more adequate trials of FDA-approved antidepressants within the current depressive episode, determined by Antidepressant Treatment History Form (ATHF-SF) criteria [score ≥ 1]

Must not have

Acute suicidality or other psychiatric crises requiring treatment escalation

Serious, unstable medical illnesses including respiratory, cardiovascular, and neurologic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trajectories from baseline/screening through 6 months post infusion

Summary

This trial will test a new medication called apimostinel as a fast-acting antidepressant with minimal side effects. The trial will also examine the effectiveness of a digital intervention called Cognitive Training in prolong

Who is the study for?

This trial is for individuals with depression. Participants should be adults who can give informed consent and are in good general health. They must not have any serious risk of suicide or a history of substance abuse, and they cannot be on certain medications that would interfere with the study.

What is being tested?

The trial is testing whether Apimostinel, given through an IV, can quickly relieve depression symptoms compared to a saline solution (a placebo). It also examines if Cognitive Training (CT) can make these benefits last longer than when no training or sham training is used.

What are the potential side effects?

Apimostinel has been reported to have minimal side effects; however, potential risks may include allergic reactions at the infusion site, headaches, nausea, or dizziness. The cognitive training itself does not typically cause side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 60 years old.

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My depression hasn't improved after trying at least one antidepressant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently experiencing a severe mental health crisis.

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I do not have any serious illnesses affecting my breathing, heart, or nervous system.

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I am currently on specific medical treatments.

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I haven't taken any MAOI drugs in the last 28 days.

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I have a neurological condition like Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of strokes or seizures.

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My high blood pressure is not well managed.

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I have serious kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trajectories from baseline/screening through 6 months post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trajectories from baseline/screening through 6 months post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and trajectories from baseline/screening through 6 months post infusion for reporting.