Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
NCT ID: NCT01868802
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ketamine treated
Ketamine
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Control, placebo treated
Placebo
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
Interventions
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Ketamine
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Placebo
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Paul J. Lamothe
OTHER
Responsible Party
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Paul J. Lamothe
Chief of the Research Department, Neurological Center.
Principal Investigators
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Paul J Lamothe, M.D.
Role: PRINCIPAL_INVESTIGATOR
American British Cowdray Medical Center
David N Lopez-Garza, M.D.
Role: STUDY_DIRECTOR
American British Cowdray Medical Center
Manuel Ruiz-Alvarez, M.D.
Role: PRINCIPAL_INVESTIGATOR
American British Cowdray Medical Center
Locations
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ABC Neurological Center
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABC KET-DRT-01-2013
Identifier Type: -
Identifier Source: org_study_id
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