Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboTerminated

The effect of intranasal ketamine on suicidality in severely depressed and suicidal patients. Randomized, placebo-controlled study

This Phase IV, randomised, double-blind, placebo-controlled, parallel-group trial (n=72) evaluated intranasal ketamine vs placebo for suicidality in patients with severe major depression awaiting ECT.

Target Enrollment
72 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, parallel two-arm trial in Finland testing intranasal ketamine (Ketalar formulation at 50 mg/ml concentration reported) against a nasal-spray placebo in severely depressed patients with significant suicidality who were awaiting ECT.

Primary endpoint was a reduction of at least six points on the SSI scale measured one day after treatment. The trial was authorised by the Finnish competent authority and favourable ethics opinion was recorded, but the global end of trial status is reported as 'Prematurely Ended' with a global end date of 2018-12-31.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Intranasal ketamine

experimental

Intranasal ketamine (marketed Ketalar formulation repurposed for intranasal use) vs placebo in parallel-group design.

Interventions

  • Ketamine
    via Other• single dose• 1 doses total

    Intranasal administration; formulation concentration recorded as 50 mg/ml in trial record; exact per-dose mg not specified.

Placebo nasal spray

inactive

Placebo nasal spray (single-dose container)

Interventions

  • Placebo
    via Other• single dose• 1 doses total

    Nasal spray placebo, single-dose container as described in EudraCT record.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • 1) Age 18–64 years.
  • 2) Severe depressive episode (clinical diagnosis of unipolar or bipolar major depressive episode).
  • 3) Severe suicidality (SSI ≥ 6).
  • 4) Clinically scheduled to start an ECT treatment series.

Exclusion Criteria

  • 1) Intoxication or withdrawal state, or positive drug screen for illegal substances, or other substance problem contraindicating ketamine administration.
  • 2) Unstable personality disorder as the primary clinical diagnosis.
  • 3) Current hallucinations. (Mood-congruent delusions such as psychotic-level hopelessness are not exclusionary.)
  • 4) Clinical diagnosis of schizophrenia or schizoaffective disorder OR lifetime history of bizarre delusions, hallucinations or other schizophrenia-like symptoms (e.g., commenting voices, thought echo/insertion/withdrawal/sending, markedly disorganised speech, frequent catatonia).
  • 5) Patient under legal Mental Health Act observation or involuntary treatment.
  • 6) Somatic contraindications preventing ketamine and/or ECT administration.
  • 7) Pregnancy: urine pregnancy test before treatment or requirement for reliable hormonal contraception or other evidence that pregnancy is not possible.

Study Details

Locations

Finland

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