Ketamine Trial for the Treatment of Depression

• Sponsor: The University of New South Wales (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02401139
• Collaborator: University of Sydney (Other)
• Enrollment: 10
• Locations: 2
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression	Drug: Ketamine; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ketamine Therapy Among Patients With Treatment-resistant Depression: a Randomised, Double-blind, Placebo-controlled Trial: Pilot Phase
• Study Start Date: Mar 1, 2015
• Anticipated Primary Completion Date: Jul 1, 2015
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment arm Ketamine	Drug: Ketamine
Placebo Comparator: Placebo arm Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brain & Mind Research Institute (BMRI), University of Sydney	Camperdown	New South Wales	Australia	2050
2	Black Dog Institute, University of New South Wales	Sydney	New South Wales	Australia	2031

Sponsors and Collaborators

• The University of New South Wales
• University of Sydney

Investigators

• Principal Investigator: Colleen K Loo, MBBS, MD, University of New South Wales

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Colleen Loo, Professor, The University of New South Wales
• ClinicalTrials.gov Identifier: NCT02401139
• Other Study ID Numbers: HREC 15009
• First Posted: Mar 27, 2015
• Last Update Posted: Mar 27, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Depression; Depressive Disorder; Ketamine

Study Results

No Results Posted as of Mar 27, 2015