esketamine hydrochloride for Major depressive disorder | Bipolar depression

Inclusion criteria

• {"criterion_text":"- male or female inpatients"}
• {"criterion_text":"- age ≥ 18 years"}
• {"criterion_text":"- ICD-11 diagnosis of severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)"}
• {"criterion_text":"- Hamilton Depression Rating Scale HAMD17 ≥ 24"}
• {"criterion_text":"- ability to understand and willingness to sign written informed consent document"}
• {"criterion_text":"- negative urine pregnancy test in women"}
• {"criterion_text":"- anesthesiological approval for ECT (Classification of the American Society of Anesthesiologists ASA ≤ 3)"}
• {"criterion_text":"- antidepressant and antipsychotic medication in steady state for at least 7 days prior to first ECT treatment"}

Exclusion criteria

• {"criterion_text":"- severe somatic or neurological disease (esp. current or previous history of intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction)"}
• {"criterion_text":"- current or past history of schizophrenia or schizoaffective disorder"}
• {"criterion_text":"- clinical relevant abnormalities on a general physical examination and routine laboratory screening"}
• {"criterion_text":"- pregnancy, breast feeding"}
• {"criterion_text":"- known allergy to the study drugs or compounds of the latter"}

Primary endpoints

• {"endpoint_text":"- HAMD17 change between baseline and post-ECT in both treatment arms over a series of 8 ECT sessions","definition_or_measurement_approach":"Change in HAMD17 score from baseline to post-ECT measured across a series of 8 ECT sessions."}
• {"endpoint_text":"- Mean recovery time over 8 ECT sessions in both treatment arms","definition_or_measurement_approach":"Mean recovery time measured across 8 ECT sessions in each treatment arm."}

Secondary endpoints

• {"endpoint_text":"- The total use of concomitant medication to treat postictal hypertension, tachycardia and agitation (urapidil, metoprolol and clonidin in mg, respectively) summed over 8 ECT sessions will be compared between the ketofol and the methohexital arms.","definition_or_measurement_approach":"Total dose (mg) of specified concomitant medications (urapidil, metoprolol, clonidin) summed over 8 ECT sessions; compared between arms."}
• {"endpoint_text":"- Ketofol anesthesia will be non-inferior to methohexital use in terms of seizure quality. The applied stimulus charge at the 8th session can be considered an indirect measure of seizure quality and duration as the stimulus charge has to be increased throughout the ECT series if seizure duration and quality are insufficient (non-inferiority margin for final stimulus charge: 20 mC).","definition_or_measurement_approach":"Applied stimulus charge at the 8th ECT session used as proxy for seizure quality; non-inferiority margin for final stimulus charge: 20 mC."}
• {"endpoint_text":"- We will assess the change of cognitive outcomes (8 tests including MMSE), as assessed using a comprehensive test battery before the first and after the last treatment (see methods section), in both treatment arms, and compare these changes between treatment arms.","definition_or_measurement_approach":"Change in cognitive test battery scores (including MMSE) from before first to after last treatment; comparison between arms."}
• {"endpoint_text":"- We will compare the average time to reorientation (TRO) over 8 ECT sessions in both treatment arms. We hypothesize that TRO might be correlated with cognitive outcomes in both treatment arms.","definition_or_measurement_approach":"Average time to reorientation (TRO) measured across 8 ECT sessions; compared between arms."}
• {"endpoint_text":"- As ketamin has a known potential of causing liver injury, laboratory markers of liver injury (ALT, AST, gamma-GT, albumin, normotest) will be monitored at baseline, at the 4th ECT session and at termination of the course.","definition_or_measurement_approach":"Laboratory monitoring of ALT, AST, gamma-GT, albumin, normotest at baseline, 4th ECT session, and end of course; occurrence of elevations compared between arms."}
• {"endpoint_text":"- We will assess changes of blood pressure and heart rate between induction of anesthesia and immediately following seizure cessation (postictal), the occurrence of agitation during recovery (assessing changes in RASS score between induction of anesthesia and recovery) and change of markers of cardiac injury (pro-BNP, troponin T, CK-MB) before, early after (0-2h) and 24h after ECT session 1, 4 and 8. These changes will be compared between treatment arms.","definition_or_measurement_approach":"Measurements of BP and HR changes induction-to-postictal, RASS score changes for agitation, and cardiac markers (pro-BNP, troponin T, CK-MB) at specified timepoints (before, 0-2h, 24h after ECT sessions 1,4,8); comparisons between arms."}

Austria

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

09-07-2024

Processing Time Days

35

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria