Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients

NCT02935595 | Completed Phase 2 Results

• 1 other identifier: HSC-MS-16-0705
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the project is to study the effect of Ketamine on cortical neurophysiological function in TRD patients. The proposal employs robust and non-invasive neurophysiological techniques TMS and EEG to investigate the cortical excitability and oscillatory activity in patients with treatment resistant depression.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (4)

• Cortical Excitability in the Dorsolateral Prefrontal Cortex (DLPFC) as Assessed by Transcranial Magnetic Stimulation-evoked Activity Detected by Electroencephalography (TMS-EEG)

  Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

  Baseline

• Cortical Excitability in DLPFC Using TMS-EEG

  Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

  4 hours

• Cortical Excitability in DLPFC Using TMS-EEG

  Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

  24 hours

• Cortical Excitability in DLPFC Using TMS-EEG

  7 days

Secondary Outcomes (4)

• Severity of Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline

• Severity of Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

  4 hours

• Severity of Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

  24 hours

• Safety as Indicated by Number of Adverse Events

  24 hours

Study Arms (1)

Ketamine

EXPERIMENTAL

Slow infusions of ketamine will take place over a time period of 40 minutes.

Drug: Ketamine

Interventions

Ketamine DRUG

Ketamine Hydrochloride Injection

Also known as: Ketamine Hydrochloride

Ketamine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 18-60 years of age
• Meet criteria for Treatment Resistant Depression (defined as two or more unsuccessful trials of antidepressants at an adequate dose for at least 4 weeks)

You may not qualify if:

• Diagnosed with intellectual disability, eg. Mental retardation, neurodegenerative diseases, eg. Early onset neurocognitive disturbances such as frontotemporal dementia or behavioral disorders, eg. adult onset Attention Deficit Hyperactivity Disorder,
• Diagnosed with Bipolar Disorder (BD),
• Diagnosed with personality disorders,
• 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 Hypertension, Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) or suffering from Chronic Obstructive Pulmonary Disease (COPD) or asthma. Cardiac clearance prior to enrolling in the study and medical records from physician will be required per patient's Primary Care Physician.
• Patients with increased risk of laryngospasm, active upper respiratory infections, respiratory depression, increased intracranial pressure, thyroid disease, 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Harris County Psychiatric Center

Houston, Texas, 77021, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Sudhakar Selvaraj, MD, PhD, Assistant Professor
• Organization: The University of Texas Health Science Center at Houston

Sudhakar.Selvaraj@uth.tmc.edu

(713) 486-2500

Study Officials

• Sudhakar Selvaraj, MBBS, DPhil

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS., DPhil (Oxon)., MRCPsych

Model Details: Open-label

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: October 14, 2016
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: January 13, 2022
• Results First Posted: August 31, 2020

Record last verified: 2022-01

Locations

US (1)