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Completed

NCT Number: NCT04239963

Behavioral and Electrophysiological Effects of Ketamine in Treatment-Resistant Depression

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. Behavioral Performance on the Probabilistic Reward Task (PRT)

    Time frame: Baseline

    The Probablilistic Reward Task operationalizes positive reinforcement learning

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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