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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

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE June 5, 2013
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Official Title  ICMJE Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depressive Disorder,
  • Treatment-Resistant Depression
Intervention  ICMJE
  • Drug: Ketamine
    A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
    Other Name: Ketalar
  • Drug: Placebo
    Saline at 0.9% intravenous infusion will be administered over 40 minutes.
Study Arms  ICMJE
  • Experimental: Ketamine treated
    Intervention: Drug: Ketamine
  • Placebo Comparator: Control, placebo treated
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01868802
Other Study ID Numbers  ICMJE ABC KET-DRT-01-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul J. Lamothe, American British Cowdray Medical Center
Study Sponsor  ICMJE Paul J. Lamothe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account American British Cowdray Medical Center
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP