Ketamine Trial for the Treatment of Depression

The University of New South Wales

Status and phase: Completed; Phase 1

Conditions: Unipolar Depression

Treatments: Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02401139

HREC 15009

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Treatment arm

Active Comparator group

Description:

Ketamine

Treatment:

Drug: Ketamine

Placebo arm

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo