Repeated Neurocognitive Measurements in Depressed Patients

NCT ID: NCT04916548

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2023-08-15

Brief Summary

In this project, we will A) track the functioning of a collection of potential neurobiological targets for depression over time, B) examine how fluctuations in the functioning of those targets relates to real-world functioning, and C) in a subset of the sample, determine how the functioning in those targets is altered by a single dose of ketamine.

Conditions

Depression, Unipolar

Study Design

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

Study Groups

Intravenous Ketamine

Open-label ketamine infusion

Group Type: EXPERIMENTAL

Intravenous Ketamine

Intervention Type: DRUG

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Interventions

Intravenous Ketamine

Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All participants will:

1. be between the ages of 18 and 60 years,

2. score ≥ 14 on the Hamilton Depression Rating Scale (Ham-D)

3. possess a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document

Exclusion Criteria

All participants:

1. Presence of lifetime bipolar, psychotic, or autism spectrum; current problematic substance use (e.g., ongoing moderate-to-severe substance use disorder);

4. Changes made to treatment regimen within 4 weeks of baseline assessment.

5. Reading level <6th grade as per patient self-report.

6. Patients who have received ECT in the past 2 months prior to Screening.

1. Patients currently taking any psychotropic medication.

2. Lifetime recreational ketamine or PCP use

3. Current pregnancy or breastfeeding

4. For ketamine phase entry, patients must be reasonable medical candidates for ketamine infusion, as determined by a physician co-investigator. Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury] will be exclusions.

5. Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for drugs of abuse], physical examination, or ECG.

6. Uncontrolled or poorly controlled hypertension, as determined by a physician co-investigator's review of vitals collected during screening and any other relevant medical history/records.

7. Patients with one or more seizures without a clear and resolved etiology.

8. Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.

9. Past intolerance or hypersensitivity to ketamine.

10. Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [e.g., riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, Dcycloserine], or the mu-opioid receptor.

11. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebecca Price

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Price

Associate Professor of Psychiatry and Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY21040075

Identifier Type: -

Identifier Source: org_study_id