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

NCT ID: NCT01868802

Last Updated: 2015-03-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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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

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Conditions

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Depressive Disorder, Treatment-Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketamine treated

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.

Control, placebo treated

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Placebo

Saline at 0.9% intravenous infusion will be administered over 40 minutes.

Intervention Type DRUG

Other Intervention Names

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Ketalar

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul J. Lamothe

OTHER

Sponsor Role lead

Responsible Party

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Paul J. Lamothe

Chief of the Research Department, Neurological Center.

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Paul J Lamothe, M.D.

Role: CONTACT

+52 (55) 11031750

David N Lopez-Garza, M.D.

Role: CONTACT

+ 52 (55) 11031750

Facility Contacts

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Eduardo San Esteban, M.D.

Role: primary

+52 (55) 52308000

Other Identifiers

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ABC KET-DRT-01-2013

Identifier Type: -

Identifier Source: org_study_id

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