Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
34
Countries
1
Sites
1
Depression
The primary objective is to assess the efficacy of ketamine for depression in adults with depression and AUD that are admitted for addiction therapy
Key facts
- Sponsor
- University Hospital Of North Norway HF
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Psychiatry and Psychology [F] - Mental Disorders [F03], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 20 Jan 2025 → ongoing
- Decision date (initial)
- 2024-02-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- The Northern Norway Regional Health Authority
External identifiers
- EU CT number
- 2023-506052-24-00
- WHO UTN
- U1111-1293-2654
- ClinicalTrials.gov
- NCT06090422
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The primary objective is to assess the efficacy of ketamine for depression in adults with depression and AUD that are admitted for addiction therapy
Secondary objectives 1
- The secondary objective is to assess safety and to provide preliminary data on whether adding a treatment series of ketamine to inpatient addiction therapy for AUD will improve treatment outcomes
Conditions and MedDRA coding
Depression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10037175 | Psychiatric disorders | 7 |
| 21.1 | LLT | 10081270 | Major depressive disorder | 10037175 |
| 20.0 | PT | 10079384 | Substance use disorder | 100000004873 |
| 21.1 | LLT | 10045543 | Unipolar depression | 10037175 |
| 20.1 | PT | 10080021 | Alcohol use disorder | 100000004873 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 18-65 years of age
- At least moderate depression without psychotic features
- Alcohol dependence as their primary substance use disorder
- Must be admitted to the hospital for inpatient addiction therapy at one of the inpatient units at University Hospital of North Norway
Exclusion criteria 9
- Not able to provide adequate informed consent
- Illegal use of ketamine the last 6 months
- Current or past history of psychotic disorder
- Significant cardiovascular event during the last year
- Liver failure or impariment of liver function
- Significant chronic kidney failure
- Significant chronic heart failure
- Significant chronic respiratory failure
- Previous anaphylactic reaction to the IMP or AMP
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is the difference in the change in MADRS from baseline to within three days from the final treatment session between intervention group and control group
Secondary endpoints 5
- Assess group differences in the change in alcohol craving from baseline
- Assess changes in alcohol consumption (measured by average number of alcohol units per week and percentage of days abstinent) from three months prior to admission until six-months post-treatment
- Assess frequency, severity and duration of ARs/SARs
- Assess and compare between groups tolerability for each treatment session (participant- and physician-reported tolerability)
- Assess within- and between-group changes in neurocognitive function from baseline to within three days from the final treatment session
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ketalar 50 mg/ml injeksjonsvæske, oppløsning
PRD358263 · Product
- Active substance
- Ketamine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- N01AX03 — KETAMINE
- Marketing authorisation
- 5724
- MA holder
- PFIZER AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Midazolam Accord 1 mg/ml, injeksjonsvæske/infusjonsvæske, oppløsning
PRD389004 · Product
- Active substance
- Midazolam Hydrochloride
- Substance synonyms
- TAK-815, SHP-615
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- 07-5068
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Of North Norway HF
- Sponsor organisation
- University Hospital Of North Norway HF
- Address
- P. O. Box 100
- City
- Tromsoe
- Postcode
- 9038
- Country
- Norway
Scientific contact point
- Organisation
- University Hospital Of North Norway HF
- Contact name
- Ole Kristian Grønli
Public contact point
- Organisation
- University Hospital Of North Norway HF
- Contact name
- Ole Kristian Grønli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 34 | 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 |
|---|---|---|---|---|---|
| Norway | 2025-01-20 | 2025-02-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ACQ-Short | 1 |
| Protocol (for publication) | AUDIT | 1 |
| Protocol (for publication) | BDI-II | 1 |
| Protocol (for publication) | CGI | 1 |
| Protocol (for publication) | D1_ Protocol 2023-506052-24-00 Redacted | 10.2 |
| Protocol (for publication) | D1_ Protocol Appendix 1 Redacted | 4 |
| Protocol (for publication) | D1_ Protocol Appendix 3 | 3 |
| Protocol (for publication) | D1_ Protocol Appendix 4 | 12 |
| Protocol (for publication) | DUDIT | 1 |
| Protocol (for publication) | EBI-EDI-MEQ | 1 |
| Protocol (for publication) | GAD-7 | 1 |
| Protocol (for publication) | KSET | 1 |
| Protocol (for publication) | MADRS | 1 |
| Protocol (for publication) | PACS | 1 |
| Protocol (for publication) | SADQ | 1 |
| Protocol (for publication) | SRH | 1 |
| Protocol (for publication) | TEA | 1 |
| Protocol (for publication) | TLFB-2024-calendar | 1 |
| Protocol (for publication) | TLFB-Instructions | 1 |
| Protocol (for publication) | WHOQOL-BREF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Ketalar | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NO 2023-506052-24-00 | 6 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NO 2023-506052-24-00 With Track Changes | 6 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-25 | Norway | Acceptable 2024-02-15
|
2024-02-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-14 | Norway | Acceptable 2024-02-15
|
2024-05-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-02 | Norway | Acceptable 2024-09-23
|
2024-09-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-28 | Norway | Acceptable 2026-04-23
|
2026-04-24 |