Clinical trial • Phase IV • Psychiatry
Thiopental sodium for Major depressive disorder
Phase IV trial of Thiopental sodium for Major depressive disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Major depressive disorder
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-12-2024
- First CTIS Authorization Date
- 27-03-2025
Trial design
Randomised, high thiopental dose versus low thiopental dose (thiopental sodium / pentocur iv); exact arm doses/schedules not specified in the ctis record.-controlled Phase IV trial across 4 sites in Sweden.
- Randomised
- Yes
- Comparator
- High thiopental dose versus low thiopental dose (thiopental sodium / Pentocur IV); exact arm doses/schedules not specified in the CTIS record.
- Target Sample Size
- 210
- Trial Duration For Participant
- 365
Eligibility
Recruits 210 No vulnerable population selected; patients under compulsory psychiatric care are excluded. Informed consent must be provided by participants who speak or understand Swedish or English sufficiently..
- Vulnerable Population
- No vulnerable population selected; patients under compulsory psychiatric care are excluded. Informed consent must be provided by participants who speak or understand Swedish or English sufficiently.
Inclusion criteria
- {"criterion_text":"- •\tage 18 years and above\n- •\thospitalized patients with an ongoing major depressive episode within MDD"}
Exclusion criteria
- {"criterion_text":"- •\tpostpartum depression\n- •\tschizophrenia\n- •\tpsychotic syndrome\n- •\tbipolar disorder\n- •\tpatients for whom the anesthesiologist deems that a high anesthetic dose is inappropriate due to a somatic condition.\n- •\tpatients under compulsory psychiatric care according to the Swedish Act on Compulsory Psychiatric Care (Lagen om psykiatrisk tvångsvård)\n- •\tpatients who do not speak or understand Swedish or English sufficiently to provide informed consent or complete study assessments"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in MADRS score measured after six ECT sessions (MADRS score change after six ECT sessions)."}
Secondary endpoints
- {"endpoint_text":"- Seizure duration in the low versus high thiopental dose group\n- Cognitive side effects within a week after ECT and after six months\n- The total number of ECT sessions in a series in the low versus high thiopental dose group\n- Length of hospital stay in the low versus high thiopental dose group\n- Awareness during anesthesia in the low versus high thiopental dose group\n- The risk for MDD relapse within a year after ECT in the low versus high thiopental dose group","definition_or_measurement_approach":"Not specified in CTIS record for individual secondary endpoints beyond their descriptions (e.g., seizure duration, cognitive side effects at specified timepoints, total number of ECT sessions, length of stay, awareness during anesthesia, MDD relapse within one year)."}
Recruitment
- Planned Sample Size
- 210
- Recruitment Window Months
- 83
- Consent Approach
- Informed consent obtained from participants themselves; participants must speak or understand Swedish or English sufficiently to provide informed consent and complete study assessments. No assent or proxy consent procedures described; patients under compulsory psychiatric care are excluded.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 210
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-03-2025
- Latest Decision Or Authorization Date
- 27-03-2025
- Processing Time Days
- 15
- Number Of Sites
- 4
- Number Of Participants
- 210
Sites
- Site Name
- Region Stockholm – SLSO
- Department Name
- Psykiatri Nordväst, Danderyds sjukhus
- Principal Investigator Name
- Nina Jovanovic
- Principal Investigator Email
- nina.jovanovic@regionstockholm.se
- Contact Person Name
- Nina Jovanovic
- Contact Person Email
- nina.jovanovic@regionstockholm.se
- Site Name
- Region Oerebro Laen
- Department Name
- Allmänpsykiatrin, Universitetssjukhuset Örebro, Region Örebro län
- Principal Investigator Name
- Axel Nordenskjöld
- Principal Investigator Email
- axel.nordenskjold@regionorebrolan.se
- Contact Person Name
- Axel Nordenskjöld
- Contact Person Email
- axel.nordenskjold@regionorebrolan.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Psykiatri Affektiva, Sahlgrenska sjukhuset
- Principal Investigator Name
- Robert Sigström
- Principal Investigator Email
- robert.sigstrom@gu.se
- Contact Person Name
- Robert Sigström
- Contact Person Email
- robert.sigstrom@gu.se
- Site Name
- Region Stockholm – SLSO
- Department Name
- S:t Görans sjukhus, Norra Stockholms psykiatri, SLSO, Region Stockholm
- Principal Investigator Name
- Carl-Johan Ekman
- Principal Investigator Email
- carl-johan.ekman@regionstockholm.se
- Contact Person Name
- Carl-Johan Ekman
- Contact Person Email
- carl-johan.ekman@regionstockholm.se
Sponsor
Primary sponsor
- Full Name
- Karolinska Institutet
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Pentocur 1 g pulver till injektionsvätska, lösning
- Active Substance
- Thiopental sodium
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 61069, authorisationCountryCode: SE)
- Maximum Dose
- 5.50 mg/kg (max total 6.00 g)
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