Neural and Antidepressant Effects of Propofol (Phase 2)

Treatment Resistant Depression Clinical Trial

Official title:

Neural and Antidepressant Effects of Propofol (Phase 2)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03923361
• Other study ID #: 00116093B
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: April 16, 2019
• Est. completion date: July 2024

Study information

• Verified date: December 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age 18-55

• Diagnosis of major depressive disorder or bipolar disorder

• Current moderate-to-severe depressive episode

• Episode duration more than 2 months and less than 5 years

• Failure of at least 2 adequate antidepressant medication trials within the past 2 years

• Body mass index < 40

• 16-item Quick Inventory of Depressive Symptomatology, self-rated > 10

Exclusion Criteria:

• Contraindication to propofol or midazolam

• Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication

• Symptomatic coronary artery disease or heart failure

• Poorly controlled hypertension or diabetes

• Abnormal kidney or liver function

• Pregnant or breast feeding

• Traumatic brain injury or significant neurologic signs (past year)

• Substance use disorder (past year)

• Obsessive compulsive disorder (current)

• Post-traumatic stress disorder (current)

• Schizophrenia-spectrum disorder (lifetime)

• Neurocognitive disorder (current)

• Personality disorder as a current focus of treatment

• ECT within the past 3 months

• Inappropriate for ECT, or poor response to ECT within the past 5 years

• Incompetent to provide consent

Related Conditions & MeSH terms

• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• Diprivan
Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.

Locations

Country	Name	City	State
United States	Univeristy Neuropsychiatric Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression	24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score < 10 Response defined as decrease of total score from baseline > 50%	3 weeks after baseline