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Ketamine-Assisted Psychotherapy for Depression (KAP Trial)

Phase 2

Recruiting

Led By James Murrough, MD, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Age 18-90 years

A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity

Must not have

Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder

Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks from baseline assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two treatments for adults with severe depression. One treatment uses ketamine combined with therapy, and the other uses only ketamine. Ketamine helps improve mood by changing brain chemistry, and therapy might make these improvements last longer. Ketamine, originally a dissociative anesthetic, has been increasingly used for treatment-resistant depression due to its rapid antidepressant effects.

Who is the study for?

This trial is for adults with major depressive disorder (MDD). Participants will be randomly assigned to receive either ketamine-assisted psychotherapy or just ketamine without psychotherapy over four weeks, followed by an 8-week observation period.

What is being tested?

The study compares two treatments for depression: one combines ketamine with psychotherapy (KAP), and the other uses only ketamine (KET). The effectiveness of each treatment will be measured through changes in depression severity and wellness.

What are the potential side effects?

Potential side effects may include dissociation, nausea, increased blood pressure, dizziness, blurred vision from ketamine. Psychotherapy generally does not have physical side effects but can sometimes cause emotional discomfort.

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 90 years old.

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I am currently experiencing moderate to severe depression.

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I have been diagnosed with major depressive disorder.

Exclusion Criteria

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

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I have experienced psychotic symptoms during my current depressive episode or have a history of psychotic disorder.

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

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I do not have any major health issues found in blood tests, physical exams, or heart tests.

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I have not responded to ketamine or esketamine treatments before.

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I am currently receiving ECT, TMS, or VNS for my depression.

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My BMI is over 35.

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My cognitive test score is below 23.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks from baseline assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks from baseline assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks from baseline assessment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Montgomery-Asberg Depression Rating Scale (MADRS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketamine Assisted Psychotherapy (KAP)Experimental Treatment2 Interventions

KAP sessions will occur once a week for a total of 4 weeks with the potential for a second session the first week for dose-finding purposes. Participants will have a ketamine exposure of at least 0.3 mg/kg and a maximum of 1.0mg/kg, at each treatment session, personalizing dose to patient experience. Each of the treatment sessions will last 120-180 min and will be conducted by a single therapist who has completed the KAP training as specified in the standard operating procedures.

Group II: Ketamine (KET)Active Control1 Intervention

Standard medicalized ketamine administration consisting of twice weekly treatment for 3 weeks, followed by a 4th week with a single ketamine infusion serving as a down-titration period before discontinuation. Participants will have a ketamine exposure of at least 0.3 mg/kg administered via intravenous infusion at each treatment session. Patients may be up-titrated over the course of subsequent treatment sessions, as indicated clinically up to 1.0 mg/kg25. No formal psychotherapy will be provided in the KET arm, though study participants will have matched basic psychoeducation related to depression and treatment with ketamine prior to the first dosing session, during the ketamine treatment period, and post-treatment, in order to match the KAP arm. All individuals will be followed over an eight week follow up period and undergo clinical study assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1120

Psychotherapy

2014

Completed Phase 3

~3440