Phase 1 Depression and Anxiety Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 70 years of age.
• People who are able to understand what the trial involves and are willing to sign a consent form agreeing to all required tests and visits.
• People who have already completed a screening assessment under a specific NIMH evaluation program (protocol 01-M-0254).
• People who have been formally diagnosed with Major Depressive Disorder (severe depression) without psychotic features, confirmed through a structured clinical interview.
• People whose depression scores on two specific rating scales fall within a required range — a depression severity score of 22 or higher on one scale (MADRS), and below 12 on a mood elevation scale (YMRS) — within one week of starting the study (confirm with trial site).
• People whose current episode of depression has not responded to at least two adequate antidepressant treatments, with at least one tried during the current episode. A failed course of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) may also count as one of these trials.
• People whose current depressive episode has been ongoing for at least four weeks.
• People who are willing to be hospitalised during the study.
• For the later open-label ketamine treatment phase: people who completed the earlier phases of the study, and people who are able to become pregnant must be willing to use at least one effective form of birth control or remain sexually abstinent throughout that phase.

Who may not be able to join:

• People who currently have psychotic symptoms, or who have a diagnosis of schizophrenia or any other psychotic disorder.
• People who have had a substance use or dependence problem (other than caffeine or nicotine) in the past three months, or who have used illicit substances in the two weeks before screening, or who return a positive drug or alcohol test at screening (excluding prescribed benzodiazepines or stimulants).
• People with serious or unstable physical health conditions, including significant liver, kidney, stomach, breathing, heart, hormonal, neurological, immune, or blood disorders.
• People who are pregnant, nursing, or physically capable of becoming pregnant, unless they agree to use at least one effective form of birth control or remain completely abstinent for the entire study period. A negative pregnancy test taken no more than 24 hours before receiving study drugs or imaging is also required.
• People with a history of seizures without a fully explained and resolved cause, or who currently take medication known to lower the seizure threshold. People with a personal or close family history of epilepsy, or who have had a stroke, brain surgery, head injury, or known structural brain lesion, would not be able to take part in the TMS procedures.
• People with any medical condition likely to affect brain structure or function (such as high blood pressure or diabetes), even if it is being treated with medication.
• People with clinically significant abnormal results on laboratory tests.
• People with a diagnosed hearing condition that may be made worse by the imaging procedures used in the study.
• People who test positive for HIV.
• People who weigh more than 119 kg.
• People who are currently taking any psychiatric medications at the point of entering the second phase of the study (medications would need to be gradually reduced during the first phase).
• People who are currently taking any non-psychiatric medications.
• People who have used any opioid medication in the past three months.
• People who have been taking a reversible monoamine oxidase inhibitor (MAOI) — a specific type of antidepressant — at the point of entering the second phase (these would need to be tapered during the first phase).
• People currently taking fluoxetine or aripiprazole at the time of screening.
• People who are unwilling to pause structured individual psychotherapy (such as CBT) during the first two phases of the study.
• People who have metallic or magnetic implants in their body, such as a pacemaker or aneurysm clip.
• People who experience discomfort in small, enclosed spaces (claustrophobia).
• People who would be unable to lie still on their back for up to 90 minutes or who would be uncomfortable in an MRI or MEG scanner.
• People who, in the investigator's judgement, are currently at serious risk of harming themselves or others.
• People with a history of aggressive behaviour towards others.
• Current NIMH employees or staff members, or their immediate family members.
• For the open-label ketamine phase: people who had a serious or intolerable reaction to ketamine during the earlier phase of the study.
• For the open-label ketamine phase: people who return a positive urine test for an illicit substance within 24 hours before ketamine treatment.
• For the open-label ketamine phase: people who are pregnant, nursing, or planning to become pregnant.

Important: Always verify eligibility with the trial site directly before applying.