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Esketamine nasal spray (Spravato) for the treatment of therapy-resistant bipolar depression. An open-label pilot trial.
EU CTIS ID: 2023-508125-27-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Known allergies against esketamine, or it's excipients
- Using ketamine in a recreative manner at present, or with recreative use in the past 6 months
- Women who are breastfeeding
- Previously been treated with esketamine or have been part of an esketamine trial
- Unable to follow instructions or unable to make their own decisions regarding treatment
- 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
See the full eligibility criteria
- 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
- Known allergies against esketamine, or it's excipients
- Using ketamine in a recreative manner at present, or with recreative use in the past 6 months
- Women who are breastfeeding
- Previously been treated with esketamine or have been part of an esketamine trial
- Unable to follow instructions or unable to make their own decisions regarding treatment
- 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
- 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
- Ketamine use disorder in their lifetime as assessed with the MINI
- An active alcohol- or drug use disorder as assessed with the MINI
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.