Clinical TrialSchizophreniaEsketaminePlaceboCompleted

Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study

Randomised, double-blind, crossover Phase III pilot (n=20) comparing IV esketamine (Ketanest S) versus active placebo (diphenhydramine) for negative and depressive symptoms in patients with schizophrenia-spectrum disorders.

Target Enrollment
20 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, two-period crossover trial in Austria (n=20) comparing IV esketamine (Ketanest S 25 mg/ml) with an active diphenhydramine placebo (Dibondrin) to assess efficacy on negative and depressive symptoms in schizophrenia-spectrum disorders.

Primary outcomes are change in the Scale for the Assessment of Negative Symptoms (SANS) and MADRS across treatment periods; secondary outcomes include PANSS, CDSS, CGI and CADSS with repeated assessments during and after each treatment period.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Esketamine

experimental

Esketamine (Ketanest S) IV treatment period of crossover design.

Interventions

  • Esketamine
    via IV• single dose

    Ketanest S (esketamine) 25 mg/ml (2 ml ampoule); dosing per protocol in treatment period.

Active placebo

active comparator

Active placebo comparator (diphenhydramine) given IV as crossover comparator.

Interventions

  • Placebo
    via IV• single dose

    Dibondrin (diphenhydramine hydrochloride, 15 mg/ml) used as active placebo; comparator described in protocol.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of schizophrenia, other non-affective psychotic disorder, or schizoaffective disorder according to DSM-5.
  • Minimum score of 60 on the Scale for the Assessment of Negative Symptoms (SANS) OR minimum score of 22 on the Montgomery–Åsberg Depression Rating Scale (MADRS).
  • Age ≥18 years.
  • Ability to provide written informed consent.
  • Female patients of childbearing potential must use an effective method of contraception (pill, vaginal ring, patch, IUD, cervical cap, condom, contraceptive injection, diaphragm).

Exclusion Criteria

  • Severe or unstable medical or neurologic disorders or clinically significant laboratory abnormalities.
  • Clinically relevant ECG abnormalities.
  • History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states.
  • Untreated or unstable arterial hypertension.
  • Established advanced arteriosclerosis or hyperthyroidism.
  • Intolerance to Ketanest® or Dibondrin®.
  • Pregnancy or lactation.
  • Current antidepressant treatment (or treatment up to two weeks prior) with an irreversible MAOI (e.g., tranylcypromine).
  • Acute suicidal or homicidal ideation.
  • Presence of ferromagnetic metal in the body or a cardiac pacemaker.

Study Details

  • Status
    Completed
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2021-09-07
  • Compounds
    EsketaminePlacebo
  • Topic
    Schizophrenia

Locations

Austria

Your Library