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Completed

NCT Number: NCT02401139

Ketamine Trial for the Treatment of Depression

This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.

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Key information

Conditions

Unipolar Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brain & Mind Research Institute (BMRI), University of Sydney, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Individuals will be eligible for enrolment on the basis of:

  • major depressive disorder for at least three months duration
  • an inadequate response to at least 2 adequate antidepressants
  • MADRS ≥ 20

Patients will be excluded on the basis of:

  • History of psychosis
  • History of bipolar disorder
  • Any unstable medical or neurologic condition
  • Any Axis I disorder other than MDD judged to be primary presenting problem
  • Planned major changes to psychotropic medication
  • Significant risk of suicide
  • Planned or probable use of ECT
  • Age under 16 years, or 16-17 years without parental consent
  • Substance abuse or dependence in previous 6 months
  • Any history of abuse of ketamine or phencyclidine
  • Contraindication to the use of ketamine
  • Planned use of ketamine
  • Women of childbearing potential not taking reliable contraception
  • Likely non-compliance with trial treatment
  • Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial

Treatment and study plan

ketamine

Drug

Placebo

Drug

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • University of Sydney

Registry information

Official study title

Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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