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

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ClinicalTrials.gov Identifier: NCT01868802
Recruitment Status : Unknown
Verified March 2015 by Paul J. Lamothe, American British Cowdray Medical Center.
Recruitment status was:  Recruiting
First Posted : June 5, 2013
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Paul J. Lamothe, American British Cowdray Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Depression Drug: Ketamine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Study Start Date : September 2013
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Changes in baseline HDRS Score [ Time Frame: 20 minutes before and 40 minutes after ketamine infusion. ]
    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.

  2. Daily change in HDRS post-ketamine infusion. [ Time Frame: 1,2,3,4,5,6 and 7. Days after ketamine infusion ]
    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 :
  1. Baseline blood pressure (BP). [ Time Frame: 20 minutes before ketamine infusion. ]
    Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.

  2. Changes from baseline in blood pressure (BP) [ Time Frame: every 5 minutes in a 300 minutes period ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Study Director: David N Lopez-Garza, M.D. American British Cowdray Medical Center
Principal Investigator: Manuel Ruiz-Alvarez, M.D. American British Cowdray Medical Center

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
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Paul J. Lamothe, 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
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