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New treatment option for Healthy Volunteer
Official title Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
ClinicalTrials.gov ID: NCT03065335
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for healthy volunteer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- All people (Main Study)
- 18 to 65 years of age.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- All people must have undergone a screening assessment under either protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders...
- Agree to be hospitalized Additional Patients with MDD (Main Study)
You likely can't join if
- Additional Exclusion Criteria: Patients with MDD (Main Study)
- Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses.
- Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.
- people with a history of DSM-IV or DSM-5 drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3...
- Treatment with a reversible MAOI within two weeks prior to Phase II.
- people who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. Exclusion Criteria: All people (Main Study)
See the full eligibility criteria
- All people (Main Study)
- 18 to 65 years of age.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- All people must have undergone a screening assessment under either protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers" or protocol 17-M-0181 ("Recruitment and...
- Agree to be hospitalized Additional Patients with MDD (Main Study)
- At the initial study enrollment, people must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. people must be experiencing a current major depressive episode of at least 2 weeks...
- At the initial screening and beginning of Phases II and III, people must have a baseline score on the MADRS \>= 20 and YMRS of \< 12.
- Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate...
- 18 to 65 years of age.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- All people must have undergone a screening assessment under either protocol 01-M-0254 "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers") or 17-M-0181 ("Recruitment and Characterization...
- Agree to be hospitalized.
- Additional Exclusion Criteria: Patients with MDD (Main Study)
- Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses.
- Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.
- people with a history of DSM-IV or DSM-5 drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, people who currently are using drugs (except for...
- Treatment with a reversible MAOI within two weeks prior to Phase II.
- people who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. Exclusion Criteria: All people (Main Study)
- Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or...
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation)...
- Clinically significant abnormal laboratory tests.
- people with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or...
- Treatment with any other concomitant medication 14 days prior to Phase II. An exception of this would be necessary for those who are taking Fluoxetine or Aripiprazole. Prior to Phase II, treatment with Fluoxetine must...
- Any use of opioid medication in the past 3 months
- Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for people doing imaging component of the study only).
- Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
- people who have hearing loss that has been clinically evaluated and diagnosed
- Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for people doing imaging component...
- Positive HIV test
- Weight \> 119 kg
- [for participants undergoing NPU Threat Test with Auditory Startle] Known history of hearing loss Additional Exclusion Criteria: Healthy Volunteers (Main Study) 1\. Current or past history of any DSM-IV or DSM-5 Axis I...
- Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).
- Current (within the past 3 months) or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine)
- Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the 4-days of the study participation (or...
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation)...
- Clinically significant abnormal laboratory tests.
- people with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.
- Treatment with any other concomitant medication.
- Any use of opioid medication in the past 3 months
- Positive HIV test
- Weight \> 119 kg
- Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for people doing neuroimaging component of the study only).
- Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for people requiring clinical MRI...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.