OxLith: exploration of the short-term physical and psychological effects of lithium in mood instability

Phase 4

Completed

• Conditions: Bipolar disorder with current mood instability; Mental and Behavioural Disorders; Bipolar affective disorder

• Registration Number: ISRCTN91624955
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26936776 protocol

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-21
• Study Completion: 2018-04-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Willing and able to give informed consent to participate in the trial
2. Meeting criteria for bipolar disorder
3. Clinical complaint of significant mood instability
4. Clinical uncertainty about the prescription of lithium
5. No clear indication for alternative treatment
6. Pre-treatment blood test results acceptable for initiation of lithium
7. Willing and able to comply with all trial requirements (assessed by a psychiatrist)
8. Willing to allow his or her General Practitioner and, if appropriate, psychiatrist to be notified of participation in the trial

Exclusion Criteria

1. Any contraindication to lithium
2. Currently taking any psychotropic drug that cannot be withdrawn
3. Clinically significant alcohol or substance use
4. Requiring immediate treatment for an acute mood episode such that placebo would be inappropriate
5. Female and pregnant, lactating or currently planning a pregnancy
6. Female of child-bearing potential not willing to use effective contraception
7. Participation in another research trial involving an investigational medicinal product in the past 12 weeks
8. Judged to be at significant immediate risk of suicide/self-harm
(Participants with contraindication to one or both brain scans will be excluded from that part of the trial)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in mood instability from weekly self-reports made online or by SMS throughout the trial (https://truecolours.nhs.uk). Depressive symptoms will be reported using the Quick Inventory of Depressive Symptoms (QIDS-SR16) scale and manic symptoms using the ALTMAN scale. Daily self-reports of current mood reported using the (Positive and Negative Affect Scale (PANAS) completed on an iPad