Esketamine nasal spray (Spravato) for the treatment of therapy-resistant bipolar depression. An open-label pilot trial.
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Academisch Ziekenhuis LeidenLeiden, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Ziekenhuis Leiden
- Trial code
- EU 2023-508125-27-00
- Record updated
- 2024. november 26.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Previously been treated with esketamine or have been part of an esketamine trial; 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; 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.