Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Negative and depressive symptoms in schizophrenia / schizoaffective disorder
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 23 Jun 2022 → ongoing
- Decision date (initial)
- 2025-02-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- FWF Austrian Science Funds Grant No. KLI958
External identifiers
- EU CT number
- 2024-519097-39-01
- EudraCT number
- 2019-004489-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To show that esketamine is superior to placebo in reducing negative and depressive symptoms in patients with a psychotic disorder
Secondary objectives 1
- To show that esketamine treatment does not lead to psychotic exacerbation in patients with a psychotic disorder
Conditions and MedDRA coding
Negative and depressive symptoms in schizophrenia / schizoaffective disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | PT | 10084992 | Negative symptoms in schizophrenia | 100000004873 |
| 21.1 | PT | 10068890 | Schizoaffective disorder depressive type | 100000004873 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Pseudonymized data will be shared upon reasonable request
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519097-39-00 | Ketamine for the treatment of depressive and negative symptoms in patients with schizophrenia: a randomized controlled cross-over pilot study. | Medical University Of Vienna |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- DSM-5 diagnosis of schizophrenia according to SCID 5
- Minimum Brief Negative Symptom Scale (BNSS (1) score of 39 (at least moderate severity across all items) or
- Minimum score of 22 on the Montgomery-Åsberg Depression Rating Scale (MADRS) (2)
- Age: 18 to 65 years
- Ability to provide written informed consent
- On stable psychopharmacological medication for at least four weeks prior to study inclusion
- 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 10
- Severe or unstable medical or neurologic disorders or clinically significant abnormality on laboratory screening results
- Clinically relevant abnormalities in the electro-cardiogram (ECG)
- History of myocardial infarction, angina pectoris, or paroxysmal hypertensive states
- Untreated or unstable arterial hypertension
- Established diagnosis of advanced arteriosclerosis or hyperthyroidism
- Intolerance to Ketanest® or Dibondrin®
- Pregnancy or lactation
- Current antidepressant treatment (or treatment up to two weeks prior to inclusion) with an irreversible MAO-inhibitor (e.g. tranylcypromine)
- Acute suicidal or homicidal ideation
- Presence of ferromagnetic metal in the body or heart pacemaker
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Change from baseline in Brief Negative Symptoms Scale (BNSS) scores after two weeks of treatment with esketamine or active placebo (diphenhydramine)
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) scores after two weeks of treatment with esketamine or active placebo
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ketanest® S 25 mg/ml - Ampullen
PRD11830403 · Product
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 275 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- 1-22525
- MA holder
- PFIZER CORPORATION AUSTRIA GES.M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD1959904 · Product
- Active substance
- Diphenhydramine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 330 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05CM, R06AA02 — OTHER HYPNOTICS AND SEDATIVES, DIPHENHYDRAMINE
- Marketing authorisation
- 7162
- MA holder
- PHARMAZEUTISCHE FABRIK MONTAVIT GES.M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of General Psychiatry
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of General Psychiatry
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-06-23 | 2022-09-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-519097-39-00_Redacted | 6 |
| Recruitment arrangements (for publication) | blank6 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Redacted | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_DibondrinAmpullen | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_KetanestAmpullen | NA |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-28 | Austria | Acceptable 2025-02-27
|
2025-02-27 |