Clinical TrialSuicidalityKetamineUnknown status

Naturalistic Study of Ketamine in the Treatment of Depression

Naturalistic, prospective observational study (n=90) assessing subcutaneous ketamine (0.5 mg/kg initial; clinician-led escalation to 0.75–1.0 mg/kg) for reducing suicide risk and depressive symptoms in patients with depressive episodes, with a healthy control group.

Target Enrollment
90 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

Prospective naturalistic study recruiting 45 patients with a major depressive episode (MDD or bipolar depression) receiving clinician-prescribed subcutaneous ketamine and 45 healthy controls for biomarker and clinical outcome assessment.

Patients receive an initial 0.5 mg/kg SC ketamine protocol (twice weekly for one month) with possible escalation to 0.75 and 1.0 mg/kg and continuation as clinically indicated; outcomes include suicide risk (C-SSRS), depressive symptoms (MADRS), and peripheral biomarkers.

Study Arms & Interventions

Ketamine

experimental

Subcutaneous ketamine for depressive episode; naturalistic dosing with clinician-led escalation.

Interventions

  • Ketamine0.5 - 1 mg/kg
    via Other• twice weekly (first month); then possibly weekly

    Subcutaneous (SC) administration; escalation to 0.75 mg/kg and 1.0 mg/kg if inadequate response per clinician.

Healthy controls

inactive

Assessments and blood collection only

Interventions

  • Compound
    via Other• single assessment

    No ketamine; baseline and follow-up assessments and blood sampling (~15 mL).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria:
  • Major depressive episode as part of Major Depressive Disorder, Bipolar I disorder, or Bipolar II disorder (DSM-5);
  • Age ≥ 18 years;
  • Able to provide written informed consent;
  • MADRS total score ≥ 12 and items 1 and 2 ≥ 2 at screening (baseline);
  • YMRS total score ≤ 11 at baseline;
  • Current symptoms of suicidal ideation and/or behaviour according to C-SSRS;
  • Effective contraceptive methods for women of childbearing potential;
  • Indication/prescription by attending physician for subcutaneous ketamine;
  • For Bipolar I: on lithium, valproic acid, or an atypical antipsychotic at therapeutic dose for ≥4 weeks prior to baseline;
  • For Bipolar II: on lithium, valproic acid, lamotrigine, or an atypical antipsychotic at therapeutic dose for ≥4 weeks prior to baseline.

Exclusion Criteria

  • Exclusion criteria:
  • Unstable, defined, or suspected systemic medical condition;
  • Pregnant, breastfeeding, or planning pregnancy within the next year;
  • Intolerance or prior adverse effects to ketamine;
  • Inability to comply with consent or protocol requirements;
  • Current psychotic symptoms (DSM-5 criteria);
  • Current diagnosis of any active substance use disorder (MINI/DSM-5), except tobacco;
  • Autoimmune or inflammatory conditions, cancer, or active infectious diseases.

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment90 participants
  • Timeline
    Start: 2021-05-01
    End: 2023-12-15
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil

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