Phase 2 Bipolar Disorder Trial, Recruiting

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

Who might be able to join this trial:

• You currently have significant depression, confirmed by a standard depression questionnaire score and a structured clinical interview
• You are currently having thoughts of death or wishing to be dead, as shown by your score on a standard questionnaire
• Your depression has not improved enough with at least one antidepressant medication you have tried in the past
• You have been diagnosed with Major Depressive Disorder (MDD), Post-Traumatic Stress Disorder (PTSD), or Bipolar Disorder, confirmed by a clinical interview
• You are currently receiving mental health treatment outside of this study (or are willing to start treatment and wait at least 4 weeks before joining)
• If you are taking medication for depression, you have been on the same medication and dose for at least 4 weeks, and you plan to stay on it throughout the trial
• If you are receiving talk therapy, you have been in that therapy for at least 4 weeks, and you plan to continue it throughout the trial
• You are willing to avoid caffeine, drugs, and alcohol for one week before each ketamine treatment session
• If you are a woman who can become pregnant, you are not currently pregnant or breastfeeding, and you agree to use an accepted form of birth control during the study (women who have had surgical sterilization or have gone through menopause for at least one year do not need to use birth control)
• If you are a woman with a regular menstrual cycle, you are willing to receive ketamine during the first week after your period starts, when possible
• You are able to read and write in English
• You have completed at least a 12th grade education or the equivalent

Who may not be able to join:

• You have expressed a clear intention or a specific plan to end your life in the past 3 months, or the study doctors consider you to be at serious risk for suicide
• You have been admitted to a psychiatric hospital in the past two months
• You have made a suicide attempt in the past two months
• You have a neurological (brain or nervous system) condition, except for migraine headaches or a mild head injury — more serious head injuries may also disqualify you (confirm with trial site for details on what counts as more than mild)
• You are currently receiving ketamine as part of your treatment
• You have previously tried ketamine without it helping you
• You are currently taking certain medications, including topiramate, memantine, or barbiturates, within two weeks of starting the trial
• You regularly take benzodiazepines (a type of anxiety or sleep medication) during the daytime
• You have taken a type of antidepressant called MAOIs (monoamine oxidase inhibitors) within 4 weeks of starting the trial
• You have received certain brain stimulation treatments (such as vagus nerve stimulation, ECT, or deep brain stimulation) within two weeks of starting the trial
• You are currently experiencing psychosis (such as hallucinations or delusions) that is not directly related to your depressed mood
• You have another serious medical condition, unless a study doctor reviews it and gives approval
• You have a history of violent behavior, unless the study doctors review your specific situation and decide it is acceptable
• You have had a diagnosis of substance use disorder or alcohol use disorder (moderate to severe) in the three months before applying — mild alcohol use disorder may be considered on a case-by-case basis (confirm with trial site)
• You test positive for drugs in a urine screen or for alcohol in a breath or saliva test
• Your heart tracing (ECG) shows a significant abnormality
• Your blood test results show significant abnormalities at the time of your medical screening, unless a study doctor decides it is safe for you to participate
• You have a known history of HIV or Hepatitis B
• You have taken certain prescribed or over-the-counter medications or herbal supplements in the week before a ketamine session — some exceptions may be allowed at the study doctors' discretion
• You have a known allergy or sensitivity to ketamine or heparin
• Your blood pressure or heart rate falls outside a certain safe range at rest, unless a study doctor reviews and approves it
• You have a history of general intellectual disability
• You have donated more than 500 mL of blood (about one pint) within 56 days before your first dose, or have lost a similar amount of blood for another reason
• The study doctors may decide to exclude you for other reasons, at their discret