At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Ebselen +1 moredrug
Likely dose
Ebselen 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Parallel Group, Double Blind, Placebo Controlled, Add on Clinical Trial to Investigate Whether the Lithium Mimetic, Ebselen, Can Reduce Symptoms of Hypomania and Mania in Bipolar Patients
In Brief
A Phase 2 clinical trial evaluating Ebselen and Placebo oral capsule for Bipolar Disorder and Bipolar Disorder, Manic. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder. Half of the participants will receive ebselen and the other half placebo. The trial, will last a total of four weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Bipolar Disorder, Manic
CountriesUnited Kingdom
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartOct 2017
Primary CompletionJul 2019
TodayJul 2026
First PostedJan 6, 2017
Enrollment StartOct 1, 2017
Primary CompletionJul 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.5 years ago
Interventions
Ebselendrug
Ebselen is an opaque capsule containing 200 mg of ebselen is a selenium-based GPx mimic and IMPase inhibitor.
Placebo oral capsuledrug
Placebo is identical in appearance to the ebselen capsules