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The UTHealth Ketamine Project

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ClinicalTrials.gov Identifier: NCT02882711
Recruitment Status : Terminated (Increasing off-label practice of IV ketamine administration for treatment-resistant depression.)
First Posted : August 30, 2016
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Salih Selek, The University of Texas Health Science Center, Houston

Brief Summary:
The primary objective of this study is to determine the effectiveness of serial infusions of intravenous (IV) ketamine in adults with treatment resistant depression (TRD).

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Bipolar Disorder Drug: Ketamine Phase 2

Detailed Description:
Thus, in the current study we want to naturalistically explore the antidepressant effects of serial slow IV infusions (40 minutes) of ketamine at a dose of 0.5 mg/kg, over a treatment period of 8 weeks in an academic psychiatric hospital. This is a minimal sedation treatment. The primary outcome measure of this study will be remission estimated based on the severity of depressive scores. After the 8 weeks of treatment, there will be a four week observational period. During the observational period, participants will receive treatment as usual and will be contacted over the phone for follow-up questions regarding their overall health status, mood and clinical state. They will also complete a neurocognitive task at the end of the 4 week observational period

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Naturalistic Study of Serial Infusion of Low-dose Ketamine for Treatment Resistant Depressive Disorders in an Academic Psychiatric Hospital: The UTHealth Ketamine Project
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: ketamine Drug: Ketamine
Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).




Primary Outcome Measures :
  1. Safety will be measured through number of adverse events [ Time Frame: Baseline through week 12 ]

Secondary Outcome Measures :
  1. Efficacy of treatment will be measured on of Clinical Global Impressions (CGI) [ Time Frame: Baseline, weeks 1 - 8 and 12 ]
  2. Reduction in severity of depressive symptoms will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, weeks 1 - 8 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with major depressive disorder (MDD) or bipolar disorder (BD)
  • patients with documented treatment resistant disorder (TRD) (according to Diagnostic Statistical Manual (DSM-IV TR)), and who have failed (defined as patient does not reach remission within the 8 week trial of an antidepressant or combination at a therapeutic dose) of at least two trials of first line evidence-based treatments and/or electroconvulsive therapy (ECT)

Exclusion Criteria:

  • Being younger than 18 of age or older than 65.
  • Diagnosed with intellectual disability, e.g. mental retardation (MR), neurodegenerative diseases, e.g. early-onset neurocognitive disturbances such as frontotemporal dementia (FTD) or behavioral disorders, e.g. adult onset Attention Deficit Hyperactivity Disorder (ADHD).
  • Diagnosed with bipolar disorder not otherwise specified (BD-NOS) or rapid cycling BD
  • Diagnosed with personality disorders (PD).
  • Previously or currently diagnosed with psychosis (schizoaffective disorder - SAD) or schizophrenia - SCZ).
  • Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., obstructive sleep apnea requiring Continuous Positive Airway Pressure (CPAP), liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases); history of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain diseases, and head injury with loss of consciousness for any period of time.
  • Diagnosed specifically with a cardiovascular disorders such as Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) or suffering from Chronic Obstructive Pulmonary Disease (COPD) or asthma. Suffering from uncontrolled hypertension or diastolic BP over 100. Cardiac clearance prior to enrolling in the study/medical records from physician will be required per patient's primary care physician (PCP).
  • Patients with increased risk of laryngospasm, active upper respiratory infections, respiratory depression, increased intracranial pressure, hyperthyroidism, or porphyria.
  • Current substance abuse or dependence. Only patients who achieved stable, full remission for at least 6 months will be included.
  • Pregnancy or Breast feeding. All female in reproductive age will undergo pregnancy tests. Female participants will be required to provide evidence of use of contraceptives during the course of the study.
  • Unable to understand the design and requirements of the study
  • Unable to sign the informed consent for any reason
  • An assigned responsible adult has provided assent to assist in patient's study participation. The responsible adult agrees to be present at each study appointment as well as provide transportation to study appointments for the patient.

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): NCT02882711


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Salih Selek, MD The University of Texas Health Science Center, Houston

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Responsible Party: Salih Selek, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02882711     History of Changes
Other Study ID Numbers: HSC-MS-16-0020
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Depressive Disorder, Treatment-Resistant
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related 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