Ketamine Trial for the Treatment of Depression

NCT02401139 | Completed Phase 1

• 1 other identifier: HREC 15009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Unipolar Depression

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale for Depression (MADRS)

  4 weeks

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

Ketamine

Drug: Ketamine

Placebo arm

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ketamine DRUG

Treatment arm

Placebo DRUG

Placebo arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The University of New South Wales: lead
• University of Sydney: collaborator

Study Sites (2)

Brain & Mind Research Institute (BMRI), University of Sydney

Camperdown, New South Wales, 2050, Australia

Location

Black Dog Institute, University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Colleen K Loo, MBBS, MD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 30, 2023

Record last verified: 2015-03

Locations

AU (2)