Clinical trial • Psychiatry

esketamine hydrochloride for Schizophrenia | Schizoaffective disorder | Depressive symptoms

Clinical trial of esketamine hydrochloride for Schizophrenia | Schizoaffective disorder | Depressive symptoms.

Overview

Trial Therapeutic Area: Psychiatry
Trial Disease: Schizophrenia | Schizoaffective disorder | Depressive symptoms
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 28-01-2025
First CTIS Authorization Date: 27-02-2025

Trial design

Randomised, active placebo comparator: dibondrin (diphenhydramine hydrochloride) solution for injection; route: intravenous infusion; product document lists max daily dose 60 mg and max total dose 330 mg. test product: ketanest® s (esketamine hydrochloride) solution for injection; route: intravenous infusion; product document lists max daily dose 50 mg and max total dose 275 mg.-controlled, crossover trial across 1 site in Austria.

Randomised: Yes
Comparator: Active placebo comparator: Dibondrin (diphenhydramine hydrochloride) solution for injection; route: intravenous infusion; product document lists max daily dose 60 mg and max total dose 330 mg. Test product: Ketanest® S (esketamine hydrochloride) solution for injection; route: intravenous infusion; product document lists max daily dose 50 mg and max total dose 275 mg.
Crossover: Yes
Target Sample Size: 20
Trial Duration For Participant: 14

Eligibility

Recruits 20 No vulnerable population selected. Participants must be able to provide written informed consent; participants are adults aged 18-65. No assent procedures or special consent-for-minors handling described..

Pregnancy Exclusion: Pregnancy or lactation
Vulnerable Population: No vulnerable population selected. Participants must be able to provide written informed consent; participants are adults aged 18-65. No assent procedures or special consent-for-minors handling described.

Inclusion criteria

{"criterion_text":"- DSM-5 diagnosis of schizophrenia according to SCID 5"}
{"criterion_text":"- Minimum Brief Negative Symptom Scale (BNSS (1) score of 39 (at least moderate severity across all items) or"}
{"criterion_text":"- Minimum score of 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS) (2)"}
{"criterion_text":"- Age: 18 to 65 years"}
{"criterion_text":"- Ability to provide written informed consent"}
{"criterion_text":"- On stable psychopharmacological medication for at least four weeks prior to study inclusion"}
{"criterion_text":"- Female patients of childbearing potential need to utilize a proper method of contraception (pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom, contraceptive injection, diaphragm)"}

Exclusion criteria

{"criterion_text":"- Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results"}
{"criterion_text":"- Presence of ferromagnetic metal in the body or heart pacemaker"}
{"criterion_text":"- Clinically relevant abnormalities in the electro-cardiogram (ECG)"}
{"criterion_text":"- History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states"}
{"criterion_text":"- Untreated or unstable arterial hypertension"}
{"criterion_text":"- Established diagnosis of advanced arteriosclerosis or hyperthyroidism"}
{"criterion_text":"- Intolerance to Ketanest® or Dibondrin®"}
{"criterion_text":"- Pregnancy or lactation"}
{"criterion_text":"- Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine)"}
{"criterion_text":"- Acute suicidal or homicidal ideation"}

Endpoints

Primary endpoints

{"endpoint_text":"- Change from baseline in Brief Negative Symptoms Scale (BNSS) scores after two weeks of treatment with esketamine or active placebo (diphenhydramine)","definition_or_measurement_approach":"Change from baseline measured using the Brief Negative Symptom Scale (BNSS) at two weeks of treatment."}
{"endpoint_text":"- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores after two weeks of treatment with esketamine or active placebo","definition_or_measurement_approach":"Change from baseline measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at two weeks of treatment."}

Recruitment

Planned Sample Size: 20
Recruitment Window Months: 36
Consent Approach: Written informed consent required from each participant (ability to provide written informed consent is an inclusion criterion). Participants are adults (18-65). A Subject Information and Informed Consent Form document is available (L1_SIS_ICF_Redacted). Languages of the consent form not specified; no assent procedures described.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 20

Austria

Earliest CTIS Part Ii Submission Date: 06-02-2025
Latest Decision Or Authorization Date: 27-02-2025
Processing Time Days: 21
Number Of Sites: 1
Number Of Participants: 20

Sites

Site Name: Medical University Of Vienna
Department Name: Division of General Psychiatry
Principal Investigator Name: Matthäus Willeit
Principal Investigator Email: matthaeus.willeit@meduniwien.ac.at
Contact Person Name: Matthäus Willeit
Contact Person Email: matthaeus.willeit@meduniwien.ac.at
Number Of Participants: 20

Sponsor

Primary sponsor

Full Name: Medical University Of Vienna
Organisation Type: Educational Institution
Country Of Registered Address: Austria

Investigational products

Investigational Product Name: Ketanest® S 25 mg/ml - Ampullen
Active Substance: esketamine hydrochloride
Modality: Small molecule
Routes Of Administration: Intravenous infusion
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation number 1-22525 in AT)
Maximum Dose: 50 mg (max daily dose)

Investigational Product Name: Dibondrin - Ampullen
Active Substance: diphenhydramine hydrochloride
Modality: Small molecule
Routes Of Administration: Intravenous infusion
Route: Intravenous infusion
Authorisation Status: Authorised (marketing authorisation number 7162 in AT)
Maximum Dose: 60 mg (max daily dose)

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