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

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
  • Placebo (DRUG)
    Saline at 0.9% intravenous infusion will be administered over 40 minutes.

Condition or Disease

  • Depressive Disorder,
  • Treatment-Resistant Depression

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Sep 01, 2013
    Primary Completion: May 01, 2016 ESTIMATED
    Completion Date: Aug 31, 2020
    Study First Posted: Jun 05, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 13, 2015

    Sponsors / Collaborators

    Lead Sponsor: Paul J. Lamothe
    Responsible Party: Paul J. Lamothe

    Location

    DF, Mexico
    Mexico City, DF, Mexico

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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.

    • On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.

    Secondary Outcomes

    • Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.

    • 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.

    More Details

    NCT Number: NCT01868802
    Other IDs: ABC KET-DRT-01-2013
    Study URL: https://clinicaltrials.gov/study/NCT01868802
    Last updated: Sep 29, 2023