2023-508125-27-00RecruitingPhase 2
Esketamine nasal spray (Spravato) for the treatment of therapy-resistant bipolar depression. An open-label pilot trial.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is an open-label pilot study of esketamine nasal spray in patients with treatment-resistant bipolar depression to assess efficacy in global, but most importantly safety and tolerability. At the current stage of drug trials involving re-designation of esketamine nasal spray, this study design is the most appropriate as this may form the base towards a future randomized, placebo-controlled trial.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 15 Aug 2024
- Start date
- 1 Apr 2025
- Lead sponsor
- Academisch Ziekenhuis Leiden
- Diseases
- Bipolar disorder
- EU CT number
- 2023-508125-27-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously been treated with esketamine or have been part of an esketamine trial
Other illness
- Known allergies against esketamine, or it's excipients
- Known cardiovascular problems that could result in severe side effects due to a rise of blood pressure, for example: intracranial, abdominal or thoracic aneurysms and patients with recent cardiovascular events (less than six weeks ago), such as a myocardial infarction
- Ketamine use disorder in their lifetime as assessed with the MINI
- An active alcohol- or drug use disorder as assessed with the MINI
Other
- Using ketamine in a recreative manner at present, or with recreative use in the past 6 months
- Women who are breastfeeding
- Unable to follow instructions or unable to make their own decisions regarding treatment
- Pregnancy as measured with a blood test at baseline
- Suicidal to a point where closed admission is needed or the C-SSRS is four or higher
- Psychosis (psychotic depression) as assessed with the MINI
Who the study is looking for
- Diagnosis of bipolar I or II disorder
- Age between 18 and 75
- MADRS scores above 18
- Current episode of depression
- Meeting the criteria of a current treatment resistant depression defined as a failure to respond to at least two different antidepressant or mood stabilizing agents during a sufficient amount of time at a sufficient dosage
- Currently be on treatment with a mood stabilizer, but may not have been treated with more than five anti-depressant therapies for the current episode
- Medication at a stable dosage for at least two weeks
- Availability on Monday and Friday
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Academisch Ziekenhuis Leiden | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.