Efficacy of Lithium versus Lamotrigine for the treatment of bipolar II disorder

Phase 3

• Conditions: Bipolar II Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12616001702404
• Lead Sponsor: Professor Gordon Parker

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-12
• Study Completion: 2020-05-26
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

The general inclusion criteria are that the patient is/has:
1. Aged 18-65
2. Having a first-onset or new onset of bipolar II disorder as per DSM-5 criteria
3. Willing to accept randomised assignment to one of the two treatment options
4. Willing to remain on all current medication at the same doses until the trial is ceased or if the managing clinician judges that such medications are unwarranted or have become contra-indicated
5. If any rescue drugs or new medications are introduced during the study, these, and reasons for their introduction will be recorded.

Exclusion Criteria

Exclusion criteria are the following:
1. Previously trialled LTG or Li
2. History of psychotic symptoms
3. Pregnancy or breast feeding (The assessing clinician will take responsibility for asking all women where appropriate if they are pregnant or possibly pregnant and if there is any doubt, a pregnancy test will be undertaken [with the patient’s consent]. All patients will be told to inform the clinician if they become pregnant during the study).
4. A medical condition which contraindicates one of the treatment groups (for instance, significant renal or cardiovascular disease)
5. Acutely suicidality
6. A substantive contributory or associated medical/alcohol/illicit drug condition or severe other co-morbid psychiatric condition

Study & Design

• Study Type: Interventional
• Study Design: Not specified