Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by American British Cowdray Medical Center
Sponsor:
Information provided by (Responsible Party):
Paul J. Lamothe, American British Cowdray Medical Center
ClinicalTrials.gov Identifier:
NCT01868802
First received: May 24, 2013
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.


Condition Intervention Phase
Depressive Disorder,
Treatment-Resistant Depression
Drug: Ketamine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

Resource links provided by NLM:


Further study details as provided by American British Cowdray Medical Center:

Primary Outcome Measures:
  • Changes in baseline HDRS Score [ Time Frame: 20 minutes before and 40 minutes after ketamine infusion. ] [ Designated as safety issue: No ]
    The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.

  • Daily change in HDRS post-ketamine infusion. [ Time Frame: 1,2,3,4,5,6 and 7. Days after ketamine infusion ] [ Designated as safety issue: No ]
    On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.


Secondary Outcome Measures:
  • Baseline blood pressure (BP). [ Time Frame: 20 minutes before ketamine infusion. ] [ Designated as safety issue: Yes ]
    Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.

  • Changes from baseline in blood pressure (BP) [ Time Frame: every 5 minutes in a 300 minutes period ] [ Designated as safety issue: Yes ]
    BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting.


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine treated Drug: Ketamine
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Other Name: Ketalar
Placebo Comparator: Control, placebo treated Drug: Placebo
Saline at 0.9% intravenous infusion will be administered over 40 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-65 years old
  • Mayor Depressive Disorder Diagnosis based on DSM-IV TR.
  • Classification of MDD as treatment-resistant.
  • No brain structural abnormalities as evidenced by an MRI scan.
  • Signed acceptance of Informed Consent.

Exclusion Criteria:

  • Other psychiatric diagnosis apart from MDD.
  • Substance abuse or dependence (prior or during study).
  • Pregnancy.
  • Congestive heart disease.
  • Personal history of psychosis.
  • First-degree relative with history of psychosis.
  • Glaucoma.
  • Present neurological disease.
  • High blood or pulmonary artery pressure.
  • Declining the signing of the informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01868802

Contacts
Contact: Paul J Lamothe, M.D. +52 (55) 11031750 paul@lamothe.com
Contact: David N Lopez-Garza, M.D. + 52 (55) 11031750 davidlopezgarza@prodigy.net.mx

Locations
Mexico
ABC Neurological Center Recruiting
Mexico City, DF, Mexico, 05300
Contact: Eduardo San Esteban, M.D.    +52 (55) 52308000    esanesteban@hotmail.com   
Principal Investigator: Paul J Lamothe Molina, M.D.         
Sponsors and Collaborators
Paul J. Lamothe
Investigators
Principal Investigator: Paul J Lamothe, M.D. American British Cowdray Medical Center
Principal Investigator: Rodrigo Perez-Esparza, M.D. National Institute of Neurology and Neurosurgery, Mexico
Study Director: David N Lopez-Garza, M.D. American British Cowdray Medical Center
Study Director: Jesus Ramirez-Bermudez, M.D. National Institute of Neurology and Neurosurgery, Mexico
Principal Investigator: Manuel Ruiz-Alvarez, M.D. American British Cowdray Medical Center
  More Information

No publications provided

Responsible Party: Paul J. Lamothe, Chief of the Research Department, Neurological Center., American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT01868802     History of Changes
Other Study ID Numbers: ABC KET-DRT-01-2013
Study First Received: May 24, 2013
Last Updated: September 13, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by American British Cowdray Medical Center:
Ketamine
Depression
Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014