A Study of Ketamine as an Antidepressant

NCT01441505 | Unknown Phase 2

• 1 other identifier: HREC 10409
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, interest has emerged in the use of ketamine as an antidepressant. Recent placebo-controlled clinical trials administering a single dose and an open label trial giving repeated doses shown that ketamine is markedly superior to placebo at reducing depression, including in treatment-resistant patients, and that its antidepressant effects have a very rapid onset. This clinical study consists of two phases. In Phase I, participants who satisfy inclusion criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or 0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II, they will receive repeated sessions of ketamine at variable doses over three weeks. During both phases, mood, psychiatric, and neuropsychological outcomes will be measured.

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• Change from baseline on depression rating scales

  Before, 4 hours after, and 24 hours after ketamine session

Secondary Outcomes (1)

• Psychiatric side effects (BPRS, CADSS) and memory tests

  Cognitive battery done before and after 3 weeks; side effects measured immediately before and 4 hours after each ketamine session in both phases.

Interventions

Ketamine DRUG

Ketamine IV, IM, or SC will be administered in Phase I and II

Saline or Midazolam (active placebo) DRUG

Saline, or midazolam 0.01mg/kg will be administered in Phase I

Eligibility Criteria

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

You may qualify if:

• Satisfy DSM-IV-TR criteria for Major Depressive Episode
• years or over
• Able to give informed consent

You may not qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
• Known sensitivity or contraindication to ketamine
• Recent drug abuse
• Pregnant

Sponsors & Collaborators

• The University of New South Wales: lead
• Wesley Mission: collaborator

Study Sites (1)

Wesley Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

Related Publications (7)

• aan het Rot M, Collins KA, Murrough JW, Perez AM, Reich DL, Charney DS, Mathew SJ. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):139-45. doi: 10.1016/j.biopsych.2009.08.038.

  PMID: 19897179 BACKGROUND

• Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.

  PMID: 10686270 BACKGROUND

• Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90.

  PMID: 20679587 BACKGROUND

• Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.

  PMID: 21557878 BACKGROUND

• Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.

  PMID: 16894061 BACKGROUND

• George D, Galvez V, Martin D, Kumar D, Leyden J, Hadzi-Pavlovic D, Harper S, Brodaty H, Glue P, Taylor R, Mitchell PB, Loo CK. Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression. Am J Geriatr Psychiatry. 2017 Nov;25(11):1199-1209. doi: 10.1016/j.jagp.2017.06.007. Epub 2017 Jun 13.

  PMID: 28739263 DERIVED

• Loo CK, Galvez V, O'Keefe E, Mitchell PB, Hadzi-Pavlovic D, Leyden J, Harper S, Somogyi AA, Lai R, Weickert CS, Glue P. Placebo-controlled pilot trial testing dose titration and intravenous, intramuscular and subcutaneous routes for ketamine in depression. Acta Psychiatr Scand. 2016 Jul;134(1):48-56. doi: 10.1111/acps.12572. Epub 2016 Mar 30.

  PMID: 27028832 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Ketamine; Sodium Chloride; Midazolam

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Colleen K Loo, MB BS FRANZCP MD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Alonzo

CONTACT

61 02 9382 3720; TMSandDCS@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 27, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

AU (1)