Ebselen as an add-on treatment in hypo/mania

Phase 1

• Conditions: Patients with bipolar disorder meeting DSM-5 criteria for hypomania or mania; MedDRA version: 19.1 Level: LLT Classification code 10000852 Term: Acute mania System Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.1 Level: PT Classification code 10021030 Term: Hypomania System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-000323-86-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

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 SCID to meet 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.
•The Clinical/GP team treating the patient are in agreement with the patient's participation

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified