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:

• People between the ages of 18 and 65 years
• People who have been diagnosed with moderate or severe cannabis use disorder in the past 3 months, test positive for cannabis on a urine screen at the start of the study, and consider cannabis their main substance of concern
• People who have been diagnosed with Bipolar I or II Disorder, or Schizoaffective Disorder (Bipolar Type)
• People who are able to understand and agree to participate, and can read and complete study questionnaires
• People who are willing to stick to the medication plan and attend follow-up appointments throughout the study
• People who are currently prescribed at least one mood-stabilising medication taken daily (such as lithium, valproate, lamotrigine, carbamazepine, or a second-generation antipsychotic)

Who may not be able to join:

• People whose primary mental health diagnosis is something other than bipolar disorder (for example, Schizophrenia)
• People who meet criteria for moderate or severe misuse of any substance other than cannabis or tobacco in the past 60 days
• People with an uncontrolled neurological condition (such as epilepsy) that could affect the study results
• People with any history of a brain injury where they lost consciousness for more than 5 minutes
• People with a history of intellectual disability or dementia, or who have had electroconvulsive therapy (ECT) in the past 3 months
• People with an uncontrolled medical condition that could affect their safety or the conduct of the study
• People with liver disease, indicated by certain liver enzyme levels being more than 3 times the normal range (confirm with trial site)
• People with kidney problems, indicated by a specific blood marker (creatinine) being more than twice the normal range (confirm with trial site)
• People currently taking certain medications that affect brain chemical systems related to glutamate or GABA — for example, benzodiazepines, memantine, ketamine, or topiramate (confirm with trial site for full list)
• People currently taking opioid medications, benzodiazepines, barbiturates, or certain other medications that could be unsafe when combined with the study drug gabapentin
• People currently taking any of the following medications: azelastine, orphenadrine, oxomemazine, paraldehyde, or thalidomide, which are generally not safe to take alongside gabapentin
• Women who are pregnant, breastfeeding, or not willing to use an adequate form of contraception during the study
• People who are currently considered at risk of harming themselves or others
• People whose depression or mood symptoms score above certain levels on standard rating scales at the start of the study (confirm with trial site)
• People who have taken gabapentin in the past month, or who have ever had a bad reaction or allergic response to it (such as severe swelling)
• People with significant claustrophobia or a history of negative experiences with MRI scans
• People who have metal implants, a pacemaker, or other materials in their body that are not safe for MRI scanning

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