Trimetazidine in Bipolar Depressio
- Conditions
- Health Condition 1: F313- Bipolar disorder, current episodedepressed, mild or moderate severity
- Registration Number
- CTRI/2023/05/052835
- Lead Sponsor
- Deakin University (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Have a DSM-V diagnosis of bipolar disorder I or II, or bipolar disorder not elsewhere classified (NEC)
2.Currently be in a major depressive episode on SCID-5-RV;Score at >= 20 on the MADRS
3. Have the capacity to consent to the study and to follow its instructions and procedures
4. Using effective contraception if a sexually active woman of a childbearing age
5. Be able to speak, read, write, and understand their national language
6. Have been on stable pre-existing pharmacological or psychotherapy regimens for 4 weeks prior to study entry (to mitigate the risk of induction of mania all participants will also need to be on an accepted mood stabiliser)
7. Participants will be required to nominate a current treating physician prior to randomisation
1. Have a known or suspected active systemic medical disorder
2. Have a primary clinical diagnosis of another disorder such as borderline personality disorder, assessed using the SCID-5-RV
3. Have a diagnosis of another psychotic disorder and/or current substance use disorder, assessed using the SCID-5-RV
4. Be undergoing electroconvulsive or transcranial magnetic stimulation therapy
5. Have contraindications (e.g., currently breastfeeding, have current or any history of renal disease/impairment, Parkinsonâ??s disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders), intolerance, or allergy to trimetazidine
6. Have a concurrent enrolment in another psychiatric clinical trial
7. Individuals who are pregnant or lactating (participants will be requested to conduct a urine pregnancy test if sexually active and of child-bearing age)
8. Inability to comply with either the requirements of informed consent or the treatment protocol
9. Any history of renal disease, Parkinsonâ??s disease, restless legs syndrome or other movement disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Improvement in depression and reduction in depression scoresTimepoint: 0,2, 4, 8 weeks
- Secondary Outcome Measures
Name Time Method Improvement in the global symptomatology and quality of lifeTimepoint: 0, 2, 4 and 8 weeks