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Ebselen as an add-on treatment in hypo/mania

Lithium is an effective prophylactic drug for patients with bipolar disorder. However, it is not well tolerated, requires regular monitoring & has a narrow therapeutic index. Identifying a drug that has the same action but is better tolerated & safer would be advantageous. Lithium has a number of possible therapeutic targets but there is good evidence that lithium's inhibition of inositol monophosphatase (IMPase) is a key mechanism in its effects. In this study we propose to test ebselen, as a potential lithium-mimetic through its ability to inhibit IMPase. Ebselen has been shown in both animal and humans to lower inositol levels. The present study of ebselen is an 'add-on' treatment in patients with hypo/mania. 60 patients will be randomised to ebselen or matching placebo for 3 weeks.

Details:

We are looking for:

Eligible

  • Informed consent 
  • Male/Female, 18-70 y 
  • Bipolar disorder: hypo/manic episode
  • Effective contraception 
  • Able to comply with trial requirements
  • The Clinical team treating the patient are in agreement

Ineligible 

  • Pregnant, lactating or planning pregnancy 
  • Renal or hepatic impairment
  • General anaesthesia during trial
  • Significant disease 
  • Participation in another research trial in the past 12 weeks
  • Illicit substance/alcohol misuse 
  • Taking lithium 
  • Previous randomisation to trial

 

Location:

  • South East

Expenses:

£20 per visit, 5 visits per completed participant.

Contact information:

Contact Clare Williams for more information:

Email: ebselen@psych.ox.ac.uk 

Phone: 01865 618315

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