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Outcome Measures

Primary Outcomes (2)

Change in suicidal ideations in response to Ketamine
Change in suicidal ideation will be assessed 24 hours post-Ketamine infusion using a Scale for Suicidal Ideation, composed of the first five items of the Beck Suicide Inventory + the Hamilton Depression Rating Scale (HAMD-7) suicidality item. The first five items of the Beck Suicide Inventory are rated on a scale of 0-2, and the suicidality item on the HAMD-7 is rated from 0-4. Scores are totaled and will be analyzed as the dependent variable in a mixed-effects model with drug condition (placebo/perampanel) and time (baseline, 24-hour follow up) as within-subject factors.
Baseline and 24 hours post infusion
Change in antidepressant response to Ketamine
Changes in depressive symptoms will be assessed 24 hours post-Ketamine infusion using the full Hamilton Depression Rating Scale (HAMD-7), a 7-item survey to assess depression. Scores range from 0-26 with scores indicating full remission (0-3) and partial/non-response (4-26). Scores are totaled and will be analyzed as the dependent variable in a mixed-effects model with drug condition (placebo/perampanel) and time (baseline, 24-hour follow up) as within-subject factors.

Study Arms (2)

Perampanel + Ketamine

EXPERIMENTAL

Participants will receive oral perampanel or placebo, in counterbalanced order, 2.5 hours before a standard, subanesthetic Ketamine infusion (0.5 mg/kg over 40 minutes). Ketamine infusions will be at least three weeks apart. Participants will refrain from caffeine and over-the-counter medication seven days before the infusion day.

Drug: Perampanel 6 MGDrug: Ketamine

Placebo + Ketamine

PLACEBO COMPARATOR

Drug: KetamineDrug: Placebo

Eligibility Criteria

Age21 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale (HDRS-17) AND current major depressive episode as determined by structured clinical interview (SCID-5)
Current suicidal ideation as indicated by a score ≥ 2 on the HDRS-17 Item #3 ("wishes to be dead (or any thoughts of possible death to self)")

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, MajorBipolar DisorderStress Disorders, Post-TraumaticSuicidal IdeationSuicide

Interventions

perampanelKetamine

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBipolar and Related DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersSelf-Injurious Behavior

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Purpose

BASIC SCIENCE

Intervention Model

CROSSOVER

Model Details: This study will include Veterans and non-Veterans. Both Veterans and non-Veterans will be included because of the large sample size of individuals currently in a major depressive episode and experiencing suicidal ideation required. Subjects with treatment-resistant depression currently in a major depressive episode and experiencing at least passive suicidal ideation. The investigators are studying this symptom complex in individuals with Major Depressive Disorder (MDD), Bipolar Disorder, and Posttraumatic Stress Disorder (PTSD). These three groups have high rates of suicide and are sensitive to Ketamine's antidepressant effects. The investigators will utilize a within-subject double-blinded, cross-over design with a counter-balanced, randomized order.

Sponsor Type

OTHER

Responsible Party

SPONSOR

The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Perampanel + Ketamine

Placebo + Ketamine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Perampanel + Ketamine

Placebo + Ketamine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations