Ebselen as an add-on Treatment in Hypo/Mania

• Status: Completed
• Trial end date: 2019-07-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Sound Pharmaceuticals, Incorporated; Stanley Medical Research Institute
• Treatments: Ebselen

Criteria

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the trial.

• Male or Female, aged 18-70 years

• Diagnosed with bipolar disorder, screened using the Structured Clinical Interview for DSM-5 (SCID) to meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Manic or Hypomanic Episode.

• Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial

• In the Investigator's opinion, is able and willing to comply with all trial requirements.

• Willing to allow clinical care team (including General Practitioner (GP)) to be made aware of trial participation.

• The Clinical team treating the patient are in agreement.

Exclusion Criteria:

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.

• Known significant renal or hepatic impairment.

• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

• Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

• Clinically significant illicit substance or alcohol misuse where dependence criteria are satisfied.

• Taking lithium.

• Previous randomisation to this trial.