OSU6162 in Bipolar Depression (OBID)
ConditionBipolar Depression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGöteborg University
About this trial
An explorative, open label, single armed, flexible dose, single center, phase IIa study of 8 weeks, initiated in subjects with bipolar depression. The study will consist of 9 visits and 1 safety visit.
Subjects with a primary diagnosis of bipolar disorder (type 1 or 2) currently in an acute depressive phase (i.e. bipolar depression) and being on stable medication with at least one mood stabilizer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Voluntary admission to the psychiatric ward prior or directly after the screening point
Age: 18-65 on the day of screening
Meeting DSM-5 criteria for a depressive episode in Bipolar Disorder type I or type II, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
Disqualifiers
Ongoing compulsory care.
Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Previously diagnosed or meeting MINI criteria at interview for obsessive-compulsive disorder or post-traumatic stress disorder.
A previous diagnosis of a personality disorder, autism, ADHD, or intellectual disability.
Trial design
Design model
Single group
Treatments tested in this trial
OSU6162
DrugOSU6162
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: OSU6162Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) at endpoint [Day 60].
Time frame
Endpoint at 60 days treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Göteborg University
Lead sponsor
Arvid Carlsson Research AB
Collaborator
Source ClinicalTrials.gov