Overview
Sponsor-declared trial summary
Major depressive disorder
The main objective of this trial is to to test if the reduction of depressive symptoms after six electroconvulsive therapy (ECT) sessions is larger in patients anesthetized with a low thiopental dose compared to patients anesthetized with a high thiopental dose during ECT.
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2025-03-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy
The main objective of this trial is to to test if the reduction of depressive symptoms after six electroconvulsive therapy (ECT) sessions is larger in patients anesthetized with a low thiopental dose compared to patients anesthetized with a high thiopental dose during ECT.
Secondary objectives 1
- Secondary research questions: Does seizure duration differ between the low and high thiopental dose groups? Are there significant differences in the cognitive side effects experienced within a week after ECT between the low and high thiopental dose groups, and do these side effects persist to a different extent after six months between the two groups? Are there differences in the total number of ECT sessions in a series between the low and high thiopental dose groups? Does the duration of hospital stay differ between the low and high thiopental dose groups? Are there differences in the occurrence of awareness during anesthesia between the low and high thiopental dose groups? Are there differences in the risk of Major Depressive Disorder (MDD) relapse within a year after ECT between the low and high thiopental dose groups?
Conditions and MedDRA coding
Major depressive disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • age 18 years and above • hospitalized patients with an ongoing major depressive episode within MDD
Exclusion criteria 1
- • postpartum depression • schizophrenia • psychotic syndrome • bipolar disorder • patients for whom the anesthesiologist deems that a high anesthetic dose is inappropriate due to a somatic condition. • patients under compulsory psychiatric care according to the Swedish Act on Compulsory Psychiatric Care (Lagen om psykiatrisk tvångsvård) • patients who do not speak or understand Swedish or English sufficiently to provide informed consent or complete study assessments
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in MADRS score after six ECT sessions with a low thiopental dose compared to a high thiopental dose for anesthesia during ECT for MDD
Secondary endpoints 1
- • Seizure duration in the low versus high thiopental dose group • Cognitive side effects within a week after ECT and after six months • The total number of ECT sessions in a series in the low versus high thiopental dose group • Length of hospital stay in the low versus high thiopental dose group • Awareness during anesthesia in the low versus high thiopental dose group • The risk for MDD relapse within a year after ECT in the low versus high thiopental dose group
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pentocur 1 g pulver till injektionsvätska, lösning
PRD10107228 · Product
- Active substance
- Thiopental Sodium
- Substance synonyms
- THIOPENTONE SODIUM
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5.50 mg/kg milligram(s)/kilogram
- Max total dose
- 6.00 g gram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AF03 — THIOPENTAL
- Marketing authorisation
- 61069
- MA holder
- ABCUR AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Nobels Vag 6
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Mikael Tiger
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Mikael Tiger
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 210 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol TIDE version 6 | 6 |
| Protocol (for publication) | Protocol TIDE version 6 clean 250312 | 6 |
| Recruitment arrangements (for publication) | forfarande-for-rekrytering-och-samtyckesprocess TIDE | 1 |
| Subject information and informed consent form (for publication) | Forskningspersonsinformation 241211 TIDE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pentocur powder for solution for injection ENG SmPC_09001bee83624e64 | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis Swedish TIDE | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-18 | Sweden | Acceptable 2025-03-27
|
2025-03-27 |