Ketamine Trial for the Treatment of Depression

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

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

Study Overview

• Status: Completed
• Conditions: Unipolar Depression
• Intervention / Treatment: Drug: Placebo; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Brain & Mind Research Institute (BMRI), University of Sydney
    • Sydney, New South Wales, Australia, 2031
      • Black Dog Institute, University of New South Wales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment arm; Ketamine	Drug: Ketamine
Placebo Comparator: Placebo arm; Placebo	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)	4 weeks

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: University of Sydney
• Investigators: Principal Investigator: Colleen K Loo, MBBS, MD, University of New South Wales

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: HREC 15009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No