The UTHealth Ketamine Project

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02882711
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• 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: Nov 7, 2016
• Actual Primary Completion Date: Aug 16, 2017
• Actual Study Completion Date: Aug 16, 2017

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Safety Will be Measured Through Number of Adverse Events [Baseline through week 12]

Secondary Outcome Measures

1. Efficacy of Treatment Will be Measured on of Clinical Global Impressions (CGI) [Baseline, week 8, week 12]

2. Severity of Depressive Symptoms as Assessed by the PHQ-9 [Baseline, week 8, week 12]

   The Patient Health Questionnaire (PHQ)-9 is the 9-item depression module from the full Patient Health Questionnaire (PHQ) PHQ-9 total score ranges from 0 to 27 (each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)), and a higher score indicates greater depression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Salih Selek, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 12, 2016

More Information

Publications

None provided.

• Responsible Party: Salih Selek, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT02882711
• Other Study ID Numbers: HSC-MS-16-0020
• First Posted: Aug 30, 2016
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Disease; Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Depressive Disorder, Treatment-Resistant; Ketamine

Study Results

Participant Flow

Pre-assignment Detail	Four participants who were enrolled met exclusion criteria and therefore did not start the study.

Arm/Group Title	Ketamine
Arm/Group Description	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).
Period Title: Overall Study
STARTED	6
COMPLETED	2
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Ketamine
Arm/Group Description	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).
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 33.3%
Male	4 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	6 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Safety Will be Measured Through Number of Adverse Events
Time Frame	Baseline through week 12

Outcome Measure Data

Analysis Population Description

This data was only collected for the 2 participants who completed the study.

Arm/Group Title	Ketamine
Arm/Group Description	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).
Measure Participants	2
Number [adverse events]	2

2. Secondary Outcome

Title	Efficacy of Treatment Will be Measured on of Clinical Global Impressions (CGI)
Time Frame	Baseline, week 8, week 12

Outcome Measure Data

Analysis Population Description

Clinical Global Impressions (CGI) scale data was not collected for any participant

Arm/Group Title	Ketamine
Arm/Group Description	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).
Measure Participants	0

3. Secondary Outcome

Title	Severity of Depressive Symptoms as Assessed by the PHQ-9
Description	The Patient Health Questionnaire (PHQ)-9 is the 9-item depression module from the full Patient Health Questionnaire (PHQ) PHQ-9 total score ranges from 0 to 27 (each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)), and a higher score indicates greater depression.
Time Frame	Baseline, week 8, week 12

Outcome Measure Data

Analysis Population Description

PHQ-9 data was collected at baseline for all 6 participants who started the study. PHQ-9 data was not collected at week 8 or week 12 for 4 participants, per study protocol.

Arm/Group Title	Ketamine
Arm/Group Description	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).
Measure Participants	6
Baseline	12.67 (9.501)
Week 8	5 (5.657)
Week 12	5 (5.657)

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Ketamine
Arm/Group Description	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).
All Cause Mortality
	Ketamine
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Ketamine
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Gastrointestinal disorders
Vomiting	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Ketamine
	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)
Psychiatric disorders
dissociation	1/6 (16.7%)	1

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.