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Ebselen as an add-on Treatment in Hypo/Mania

NCT03013400 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ebselen

Ebselen is an opaque capsule containing 200 mg of ebselen is a selenium-based GPx mimic and IMPase inhibitor.

DRUG

Placebo oral capsule

Placebo is identical in appearance to the ebselen capsules

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

  • Stanley Medical Research Institute

    collaborator OTHER

  • Sound Pharmaceuticals, Incorporated

    collaborator INDUSTRY

Principal Investigators

  • Philip J Cowen, MBBS, MD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-07-09
Completion
2019-07-09

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013400 on ClinicalTrials.gov