Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

NCT04239963 | Completed

• 1 other identifier: 2019P003371
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of the present study is to evaluate the effect of a subanesthetic dose of ketamine 24-hour post-injection on resting state functional connectivity, cognitive control, and reward learning.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (5)

• Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials

  Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).

  Baseline

• Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials.

  Relative ERN response is the primary outcome measure for the flanker task.

  Baseline

• Behavioral Performance on the Probabilistic Reward Task (PRT)

  The Probablilistic Reward Task operationalizes positive reinforcement learning

  Baseline

• Behavioral Performance on the Flanker Task

  The Flanker Task is a cognitive task that measures response inhibition to assess the ability to suppress responses that are inappropriate in a particular context.

  Baseline

• Rumination

  Severity of rumination will be assessed using the Rumination Response Scale (RRS). The RRS has a minimum score of 22 and a maximum score of 88. Higher scores indicate higher degrees of ruminative symptoms.

  Baseline

Study Arms (2)

Healthy Controls

Subjects who have no history of clinical depression or other psychological disorder

Current MDD

Subjects experiencing a current episode of Major Depressive Disorder.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit 30 TRD individuals with current MDD without psychotic features and 30 demographically matched healthy controls. All participants will be ketamine-naïve.

You may qualify if:

• All genders, races, and ethnic origins, aged between 18 and 70;
• DSM-5 diagnostic criteria for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5));
• A score of ≥32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30).
• Capable of providing written informed consent, and fluent in English;
• Right-handed;
• Treatment Resistant (as assessed using the MGH Antidepressant Response Questionnaire)
• Have already decided to receive ketamine treatment as part of their standard clinical care
• All genders, races, and ethnic origins, aged between 18 and 70;
• Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP);
• A baseline Quick Inventory of Depressive Symptomatology (QIDS) score ≤ 5;
• A baseline Hamilton Depression Rating Scale (HDRS) score ≤ 7;
• Capable of providing written informed consent, and fluent in English;
• Right-handed;
• No first-degree relative with mood or psychotic disorder.

You may not qualify if:

• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
• History of seizure disorder;
• History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder;
• Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication;
• Substance use assessed by physician as dangerous for ketamine treatment;
• Untreated glaucoma;
• Complex post-traumatic stress disorder (PTSD) with dissociation;
• Patients with a lifetime history of electroconvulsive therapy (ECT).
• Participants with a lifetime history of ketamine use.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Diego Pizzagalli, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Depression, Anxiety and Stress Research

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 27, 2020
• Study Start: August 17, 2020
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

US (1)