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NMDA Receptor Antagonist

Ketamine-Enhanced Psychotherapy for PTSD

Phase 2

Recruiting

Led By Ilan Harpaz-Rotem, PhD ABPP

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Male or female between the ages of 21-70 years

Diagnosis of PTSD with a score of 25 or higher (i.e. severe PTSD) on the Clinician-Administered PTSD Scale (CAPS-5) at screening

Must not have

Any signs of major medical or neurological illness on examination or as a result of ECG screening or laboratory studies

Subjects on a prohibited medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 7 days, 30 days and 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if ketamine + intensive psychotherapy can help relieve PTSD faster than midazolam + psychotherapy. It may produce significant changes in a week, vs months.

Who is the study for?

Adults aged 21-70 with severe PTSD who can read and write English may join this trial. They must not be pregnant, agree to birth control if applicable, have stable mental health without certain disorders like schizophrenia or bipolar mania recently, and no recent substance abuse. Participants should not have medical conditions that make ketamine unsafe.

What is being tested?

The study is testing whether a week-long intensive psychotherapy combined with either ketamine or midazolam is more effective for treating PTSD. It aims to achieve results faster than traditional methods and will also examine changes in brain function as a result of the treatment.

What are the potential side effects?

Ketamine might cause disorientation, dizziness, nausea, increased blood pressure, mood swings, or dissociative experiences. Midazolam can lead to sleepiness, memory issues, reduced alertness and coordination problems.

Eligibility Criteria

Inclusion Criteria

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

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I am between 21 and 70 years old.

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I have severe PTSD with a CAPS-5 score of 25 or higher.

Exclusion Criteria

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

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I do not have any major illnesses found through physical exams or tests.

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I am not taking any medications that are not allowed in the study.

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I have a history of serious illness.

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I am not pregnant, breastfeeding, or have a positive pregnancy test.

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My body weight is 250 pounds or more.

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I have not donated more than 500 mL of blood in the last 56 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 7 days, 30 days and 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 7 days, 30 days and 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 7 days, 30 days and 90 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Amygdala activation to trauma memory (Phase 1; R61)

To determine if ketamine + exposure therapy results in clinical improvement in PTSD symptoms which are significantly greater than midazolam + exposure therapy (Phase 2; combined R61/R33 data)

To determine if ketamine + exposure therapy results in more profound changes in task-based connectivity in region of interest than midazolam + exposure therapy (Phase 2; combined R61/R33 data)

Secondary study objectives

Change from baseline to 90 days post treatment in Beck Depression Inventory (BDI-II)

Measure the changes in psychophysiological distress to trauma reminders as a result of the proposed intervention

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

Active Control

Group I: 0.5mg/kg ketamine with psychotherapyExperimental Treatment1 Intervention

2. Two infusions of Ketamine combined with trauma-focused psychotherapy. Low dose ketamine infusion will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state of ketamine infusion of 0.5 mg/kg for 40 minutes.

Group II: 0.2mg/kg ketamine with psychotherapyExperimental Treatment1 Intervention

Two infusions of low dose Ketamine combined with trauma-focused psychotherapy. Low dose ketamine infusion will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee and administer the ketamine infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following ketamine infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady state of ketamine infusion of 0.2 mg/kg for 40 minutes.

Group III: Midazolam with psychotherapyActive Control1 Intervention

Midazolam combined with trauma-focused psychotherapy. Midazolam infusion procedure will take place on day 2 and day 4, of the psychotherapy intervention. A physician will oversee administer the Midazolam infusions. A nurse will accompany the subject throughout the study sessions, from the insertion of bilateral cannula for drug infusion and blood sampling, to the recovery following midazolam infusion. Whilst subjects undergo the infusion, their heart rate and blood pressure will be constantly monitored. The participant will receive a steady midazolam infusion at a rate 0.045 mg/kg for 40 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1120

0 / 8Eligibility criteria met