The UTHealth Ketamine Project

NCT ID: NCT02882711

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-07
• Study Completion Date: 2017-08-16

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).

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

Conditions

Treatment Resistant Depression; Major Depressive Disorder; Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ketamine

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Salih Selek

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salih Selek, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-16-0020

Identifier Type: -

Identifier Source: org_study_id