ESKETAMINE for Bipolar disorder, depressive episode

Inclusion criteria

• {"criterion_text":"- Diagnosis of bipolar I or II disorder\n- Age between 18 and 75\n- MADRS scores above 18\n- Current episode of depression\n- Meeting the criteria of a current treatment resistant depression defined as a failure to respond to at least two different antidepressant or mood stabilizing agents during a sufficient amount of time at a sufficient dosage\n- Currently be on treatment with a mood stabilizer, but may not have been treated with more than five anti-depressant therapies for the current episode\n- Medication at a stable dosage for at least two weeks\n- Availability on Monday and Friday"}

Exclusion criteria

• {"criterion_text":"- Known allergies against esketamine, or it's excipients\n- Using ketamine in a recreative manner at present, or with recreative use in the past 6 months\n- Women who are breastfeeding\n- Previously been treated with esketamine or have been part of an esketamine trial\n- Unable to follow instructions or unable to make their own decisions regarding treatment\n- Known cardiovascular problems that could result in severe side effects due to a rise of blood pressure, for example: intracranial, abdominal or thoracic aneurysms and patients with recent cardiovascular events (less than six weeks ago), such as a myocardial infarction\n- Pregnancy as measured with a blood test at baseline\n- Suicidal to a point where closed admission is needed or the C-SSRS is four or higher\n- Psychosis (psychotic depression) as assessed with the MINI\n- Ketamine use disorder in their lifetime as assessed with the MINI\n- An active alcohol- or drug use disorder as assessed with the MINI"}

Primary endpoints

• {"endpoint_text":"- Efficacy as determined by response and remission rates: response is defined as a 50% or more reduction of the MADRS score. Remission is defined as a MADRS score that falls under ten.","definition_or_measurement_approach":"Response: a 50% or more reduction of the MADRS score. Remission: MADRS score < 10. Efficacy determined by response and remission rates."}

Secondary endpoints

• {"endpoint_text":"- Safety will be determined by the number of side effects. The potential effect of conversion to mania will be measured by a YMRS of 20 or more points, indicating at least a mild mania. All other psychiatric side effects, such as psychosis and suicidality as well as somatic side effects will be meticulously monitored.","definition_or_measurement_approach":"Safety measured by number of side effects; conversion to mania measured by YMRS ≥ 20; other psychiatric and somatic side effects monitored."}
• {"endpoint_text":"- Tolarability will be determined by dropout rates during the whole study.","definition_or_measurement_approach":"Tolerability measured by dropout rates during the study."}
• {"endpoint_text":"- Relapse will be monitored and measured by: admission to a psychiatric hospital or ward due to depressive symptoms; a suicide attempt or admission to prevent suicide; an increase in depressive symptoms measured by the MADRS of >25% or above 22 points after initial response or remission following treatment.","definition_or_measurement_approach":"Relapse defined as psychiatric admission for depressive symptoms, suicide attempt or preventive admission, or MADRS increase >25% or >22 points after initial response/remission."}

Netherlands

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

26-11-2024

Processing Time Days

22

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Academisch Ziekenhuis Leiden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands