Clinical TrialMajor Depressive Disorder (MDD)KetamineKetamineRecruiting

Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression (KAP)

Single-site, randomised, controlled RCT (n=70) comparing ketamine-assisted psychotherapy (KAP) to standard medical ketamine (KET) for MDD over four weeks; ketamine doses personalised 0.3–1.0 mg/kg.

Target Enrollment
70 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

Randomised, parallel-group, single-blind (outcomes assessor) trial enrolling adults with major depressive disorder to receive either weekly KAP sessions (IM ketamine, 0.3–1.0 mg/kg, 4–5 sessions) or a standard medical IV ketamine regimen (twice-weekly for three weeks then a single infusion in week four, up to seven infusions).

Assessments include depression severity, wellness, neurocognitive functioning and safety at baseline, end of acute treatment, and over an eight-week follow-up. Preparatory and integration psychotherapy sessions are provided in the KAP arm; matched psychoeducation provided in the KET arm.

Study Protocol

Preparation

1 sessions

Dosing

7 sessions
180 min each

Integration

5 sessions
60 min each

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

KAP

experimental

Ketamine-assisted psychotherapy: weekly KAP sessions for 4 weeks (possible second session in week 1 for dose finding); personalised ketamine dosing IM.

Interventions

  • Ketamine0.3 - 1 mg/kg
    via IM• weekly• 5 doses total

    Personalised dosing 0.3–1.0 mg/kg; session duration 120–180 min; preparatory and integration sessions included.

  • Compound
    via Other

    Behavioral psychotherapy and integration sessions paired with drug sessions (60 min integration sessions weekly).

KET

active comparator

Standard medical ketamine without formal psychotherapy: twice-weekly IV infusions for 3 weeks then a single infusion in week 4; dose titrated clinically 0.3–1.0 mg/kg.

Interventions

  • Ketamine0.3 - 1 mg/kg
    via IV• twice weekly for 3 weeks then single infusion week 4• 7 doses total

    No formal psychotherapy; matched basic psychoeducation provided.

Participants

Ages
18 – 90
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria
  • Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.
  • Age 18-90 years
  • Participant in good physical health
  • Participants may be on medications for depression as long as they remain on a stable dose.
  • A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity.
  • Meets criteria for major depressive disorder (MDD) in current major depressive episode (MDE) according to DSM-5
  • Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion

Exclusion Criteria

  • Exclusion Criteria
  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease
  • Clinically significant abnormalities of laboratories, physical examination, or ECG
  • Substance drug or alcohol use disorder in the prior 12 months
  • History of hypersensitivity to ketamine or esketamine
  • Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder
  • Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder
  • Recreational ketamine or phencyclidine use in the last year
  • Previous non-response to clinical or research ketamine or esketamine administration
  • Concurrent treatment with ECT, TMS, or VNS in the current MDE
  • BMI > 35
  • Significant suicidal ideation as determined by a C-SSRS score >2 in past 30 days
  • History of suicide attempt or self harm in the prior 2 years
  • SBP > 165 or DBP > 95 on infusion day
  • MoCA score < 23

Study Details

Locations

Icahn School of Medicine at Mount Sinai — New York, New York, United States

Your Library