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NMDA Receptor Antagonist

Ketamine for Depression

Phase 1

Recruiting

Led By Carlos A Zarate, M.D.

Research Sponsored by National Institute of Mental Health (NIMH)

Eligibility Criteria Checklist

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

Must have

Phases I-II

Subjects must have an initial score on the MADRS greater than or equal to 22 and a YMRS score of <12 within one week of study entry and upon entry into Phase II

Must not have

Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study)

Weight > 119 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 1, day 2 day 7

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if the antidepressant response of ketamine is linked to AMPA receptors.

Who is the study for?

Adults aged 18-70 with major depressive disorder without psychotic features, who haven't responded to two antidepressant trials. They must be willing to stay at the NIH Clinical Center for 5 weeks and agree to tests like blood draws, MRI, MEG, and possibly sleep tests or TMS. Women able to get pregnant should use birth control or abstain from sex.

What is being tested?

The trial is testing if ketamine's rapid antidepressant effects are related to AMPA receptors in the brain. Participants will stop taking current psychiatric meds, undergo various tests including brain imaging, then receive either a study drug or placebo orally before getting an intravenous ketamine infusion while their brain activity is monitored.

What are the potential side effects?

Ketamine may cause side effects such as dissociation (feeling detached), dizziness, nausea, increased blood pressure and heart rate shortly after infusion. Long-term side effects are not well known but could include cognitive changes or bladder problems with repeated use.

Eligibility Criteria

Inclusion Criteria

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

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My trial is in an early phase (I or II).

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My depression is moderate to severe, and I have low to no mania symptoms.

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My depression is moderate to severe, and I have low or no mania symptoms.

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I have been experiencing a major depressive episode for at least four weeks.

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I am between 18 and 70 years old.

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I have been diagnosed with Major Depression without psychosis.

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I am not willing to pause my current psychotherapy sessions.

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I weigh more than 119 kg.

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I have not had seizures, epilepsy, stroke, brain surgery, head injury, or known brain issues.

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I am currently taking fluoxetine or aripiprazole.

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I have used opioid medication in the last 3 months.

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I cannot lie on my back comfortably for 90 minutes.

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I have a condition like high blood pressure or diabetes that could affect my brain.

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I do not have any serious, unstable illnesses affecting my organs or immune system.

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I had a severe reaction to ketamine in a previous phase.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 1, day 2 day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 1, day 2 day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 2 day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Antidepressant Efficacy: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) score post ketamine infusion

Continued Antidepressant Efficacy: Change from baseline MADRS score post treatment with ketamine with perampanel versus placebo.

Secondary study objectives

Acute Antidepressant Efficacy: Change in peripheral measures associated with the administration of ketamine

Acute Antidepressant Efficacy: Change in slow wave activity/slope post ketamine infusion

Acute Antidepressant Efficacy: Change in synaptic plasticity post ketamine infusion

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: 3Experimental Treatment2 Interventions

Individuals in Arm 3 will receive double-blinded placebo and open-label ketamine on the first day, then double-blinded placebo on the second day.

Group II: 2Experimental Treatment4 Interventions

Individuals in Arm 2 will receive double-blinded placebo and open-label ketamine on the first day, then double-blinded perampanel on the second day.

Group III: 1Experimental Treatment3 Interventions

Individuals in Arm 1 will receive double-blinded perampanel and open-label ketamine on the first day, then double-blinded perampanel on the second day.

0 / 16Eligibility criteria met