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Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT04239963
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital

Tracking Information
First Submitted Date January 15, 2020
First Posted Date January 27, 2020
Last Update Posted Date August 24, 2022
Actual Study Start Date August 17, 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2020)
  • Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials [ Time Frame: Baseline ]
    Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).
  • Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials. [ Time Frame: Baseline ]
    Relative ERN response is the primary outcome measure for the flanker task.
  • Behavioral Performance on the Probabilistic Reward Task (PRT) [ Time Frame: Baseline ]
    The Probablilistic Reward Task operationalizes positive reinforcement learning
  • Behavioral Performance on the Flanker Task [ Time Frame: Baseline ]
    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.
  • Rumination [ Time Frame: Baseline ]
    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.
Original Primary Outcome Measures
 (submitted: January 21, 2020)
  • Feedback-related positivity (FRP) amplitudes over frontocentral scalp regions in response to rewarded trials versus no-reward trials [ Time Frame: Baseline ]
    Relative FRP response is the primary outcome measure for the probabilistic reward task (PRT).
  • Event-related negativity (ERN) amplitudes over frontocentral scalp regions in response to correct trials versus incorrect trials. [ Time Frame: Baseline ]
    Relative ERN response is the primary outcome measure for the flanker task.
  • Behavioral Performance on the Probabilistic Reward Task (PRT) [ Time Frame: Baseline ]
    The Probablilistic Reward Task operationalizes positive reinforcement learning
  • Behavioral Performance on the Flanker Task [ Time Frame: Baseline ]
    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.
  • Rumination [ Time Frame: Baseline ]
    Severity of rumination will be assessed using the Rumination Response Scale (RRS)
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression
Official Title Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression
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.
Detailed Description

Major Depressive Disorder (MDD) participants with treatment-resistant depression (TRD) will be recruited from McLean's Ketamine clinic. Suitability for Ketamine treatment will be determined as typically done by the service - through evaluation by the clinicians on the staff of the Ketamine Service who perform psychiatric consultations and assessments for Ketamine suitability. Potential subjects will be informed about the study only after they have received a positive consultation at the clinic and have already agreed to receive the treatment.

This study consists of a set of questionnaires, urine drug screen, and electroencephalogram (EEG) recordings.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Major Depressive Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2020)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria (MDD Subjects):

  • 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

Inclusion Criteria (Control Subjects):

  • 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.

Exclusion Criteria (All Subjects):

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jason Scott, BA 617-855-2247 jscott@mclean.harvard.edu
Contact: David Crowley, ALM 617-855-4432 djcrowley@mclean.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04239963
Other Study ID Numbers 2019P003371
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Diego A. Pizzagalli, Mclean Hospital
Original Responsible Party Same as current
Current Study Sponsor Mclean Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Diego Pizzagalli, PhD Mclean Hospital
PRS Account Mclean Hospital
Verification Date August 2022