Ketamine Trial for the Treatment of Depression

Unipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401139
• Other study ID #: HREC 15009
• Status: Completed
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2015
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Drug:
• Ketamine

• Placebo

Locations

Country	Name	City	State
Australia	Brain & Mind Research Institute (BMRI), University of Sydney	Camperdown	New South Wales
Australia	Black Dog Institute, University of New South Wales	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
The University of New South Wales	University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		4 weeks