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Nebulized Ketamine for the Treatment of Major Depressive Disorder

ConditionsSevere DepressionModerate DepressionKetamineMidazolamPeripheral Nervous System AgentsCentral Nervous System AgentsNeurotransmitter AgentsPhysiologic Effects of DrugsSensory System AgentsAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalDepressive SymptomHypnotics and SedativesAnti-anxiety AgentsTranquilizing AgentsPsychotropic DrugsAnesthetics Agent
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-88
SponsorTheresa Jacob, PhD, MPH

About this trial

This is a double-blind active placebo controlled clinical trial for individuals with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All individuals 18 years and older with a Montgomery-Asberg Depression Rating Scale score (MADRS) ≥ 20

Must have a diagnosis of moderate to severe Major Depressive Disorder (MDD)

Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis

Disqualifiers

Adult patients with an allergy to Ketamine

Adult patients with an allergy to Midazolam

Individuals with a history of mania/hypomania or diagnosis of bipolar disorder

Patients on lithium and/or lamotrigine therapy

Trial design

Design model

Crossover

Treatments tested in this trial

  • nebulized ketamine

    Drug

    The formulation of the study drug is administered via nebulizer in which the participants inhales the study drug. The dosage is calculated by body weight (1.5mg/kg).

  • nebulized midazolam

    Drug

    The formulation of the active comparator drug is administered via nebulizer in which the participant inhales the study drug. The dosage is calculated by body weight (0.03mg/kg).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Nebulized MidazolamActive comparator 1 intervention
Group B: Nebulized KetamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS)

Montgomery-Asberg Depression Rating Scale (MADRS) has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total Montgomery Asberg Depression Rating Scale (MADRS) score from the baseline (pre-dose day 1 ), Day 2 and last day of assessments (Day 8 or Day 10)

Time frame
8-10 days

Secondary outcomes

1

A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1) and 2 hours post-medication administration

Montgomery-Asberg Depression Rating Scale (MADRS) has a range from 0 to 60, where the lower score indicates the better health status. Change in mean total MADRS prior to dose administration on Day 1, 2 hours after dose administration for each day.

Time frame
8-10 days
2

Change in Beck Scale for Suicide Ideation

Beck Scale for Suicide Ideation (SSI) has a range from 0 to 42, where the lower score indicates the better health status. SSI score of ≥4, response which would be defined as SSI ≥50% below baseline - 2 hours post medication administration and remission defined as SSI score of ≥50% and lower than 4 - 24 hrs after medication administration of follow-up

Time frame
24 hours
3

Clinician-Administered Dissociative States Scale (CADSS)

Measurement of dissociative symptoms. Clinician Administered Dissociative States Scale (CADSS) comprises 23 subjective items, each on a 5 point scale, a "0" represents absence of any adverse events and "4" represents a severely bothersome side effect. A total score ranges from 0-92, a lower score indicates a better health status.

Time frame
8-10 days
4

Side Effect Rating Scale for Dissociative Anesthetics (SERSDA)

Overall side effects as measured by the Side Effect Rating Scale for Dissociative Anesthetics (SERSDA). SERSDA has 9 items, each graded on a five point scale, with "0" representing the absence of any adverse effects and "4" representing a severely bothersome side effect.

Time frame
8-10 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Theresa Jacob, PhD, MPH

Lead sponsor

Maimonides Medical Center

Sponsor institution

Source ClinicalTrials.gov
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