The UTHealth Ketamine Project

NCT02882711 | Terminated Phase 2 Results

• 1 other identifier: HSC-MS-16-0020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Treatment Resistant Depression; Major Depressive Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Safety Will be Measured Through Number of Adverse Events

  Baseline through week 12

Secondary Outcomes (2)

• Efficacy of Treatment Will be Measured on of Clinical Global Impressions (CGI)

  Baseline, week 8, week 12

• Severity of Depressive Symptoms as Assessed by the PHQ-9

  Baseline, week 8, week 12

Study Arms (1)

ketamine

EXPERIMENTAL

Drug: Ketamine

Interventions

Ketamine 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).

ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Bipolar Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Not reaching the target number of participants needed to achieve target power

Results Point of Contact

• Title: Salih Selek, M.D.
• Organization: The University of Texas Health Science Center at Houston

salih.selek@uth.tmc.edu

713-741-3936

Study Officials

• Salih Selek, MD

  The University of Texas Health Science Center, Houston

  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: Associate Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 30, 2016
• Study Start: November 7, 2016
• Primary Completion: August 16, 2017
• Study Completion: August 16, 2017
• Last Updated: November 24, 2020
• Results First Posted: November 9, 2020

Record last verified: 2020-11

Locations

US (1)