Clinical TrialMajor Depressive Disorder (MDD)KetamineTerminated

KAP for Depression in Abstinent Opioid Users (KReDO)

Terminated single-group Phase II study (n=5) of intramuscular ketamine (0.5→1.5 mg/kg, up to 60 mg) weekly for 8 weeks with psychotherapy for adults (18–64) with MDD and opioid use disorder in remission.

Target Enrollment
5 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This single-group Phase II study evaluated ketamine-assisted psychotherapy in adults with major depressive disorder and opioid use disorder in early or sustained remission. Participants received eight weekly intramuscular ketamine sessions (starting 0.5 mg/kg with escalation to 1.5 mg/kg or a 60 mg cap) paired with psychotherapy before, during and after dosing.

Eligibility required MADRS ≥20 and stability on other psychotropic medications; primary outcomes included depression symptom change and safety/tolerability measured across a 16-week participation period including follow-up.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine-assisted psychotherapy

experimental

8 weekly IM ketamine injections (0.5→1.5 mg/kg or max 60 mg) with psychotherapy before, during and after each session.

Interventions

  • Ketamine0.5 - 1.5 mg/kg
    via IM• weekly• 8 doses total

    Escalation to 1.5 mg/kg or max 60 mg; psychotherapy provided before/during/after sessions.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria
  • A subject may be eligible for enrollment if all the following inclusion criteria apply within the thirty days prior to first experimental session:
  • 1. Between the ages of 18 to 64 years old.
  • 2. Able to provide informed consent.
  • 3. Meet DSM-5 criteria for Major Depressive Disorder, without psychotic features based on clinical interview.
  • 4. Score at least 20 on the Montgomery-Asberg Depression Rating Scale (MADRS, moderate or severe depression).
  • 5. Must meet criteria for opioid use disorder in early or sustained remission criteria by DSM-5 based on clinical interview.
  • 6. Subjects taking other psychotropic medications (e.g. anti-depressants, anxiolytics, methadone, buprenorphine, naltrexone) must be maintained on a stable dose for at least four weeks before study initiation.

Exclusion Criteria

  • Exclusion Criteria
  • Subjects will be excluded from the study if any of the following criteria apply:
  • 1. They are considered an immediate suicide risk by clinician assessment, self-reports a suicide attempt within the past year, or felt to be likely to require hospitalisation during the study.
  • 2. Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.
  • 3. Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders based on clinical interview.
  • 4. Subjects meeting DSM-5 criteria for current substance use disorder (i.e., not in early or sustained remission) other than tobacco use disorder.
  • 5. Subjects who report use of ketamine >20 times in the past or who meet DSM-5 criteria for Other Hallucinogen Use Disorder due to ketamine use including subjects who are currently in early or sustained remission.
  • 6. Women who are pregnant or nursing, and women who do not consent to use methods of highly effective birth control during the interventional phase of the study.
  • 7. Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
  • 8. A history of allergic or other adverse reaction to ketamine (or its excipients).
  • 9. Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).
  • 10. QTc will be measured in all subjects and those with QTc 450ms or longer will be excluded.
  • 11. Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study.
  • 12. Subjects with kidney or liver impairment.

Study Details

Locations

Medical University of South Carolina Centerspace — Charleston, South Carolina, United States

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