TIDE (Trimetazidine in bipolar depression): A double-blind, randomised, placebo-controlled trial

Phase 2

• Conditions: Bipolar depression; Mental Health - Depression; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622000474752
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-25
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

I.Aged 18-65 years;
II.Have a DSM-V diagnosis of bipolar disorder I or II, or bipolar disorder not elsewhere classified (NEC);
III.Currently be in a major depressive episode on Structured Clinical Interview for DSM Disorders (SCID-5-RV);
IV.Score greater than or equal to 20 on the Montgomery Åsberg Depression Rating Scale (MADRS);
V.have the capacity to consent to the study and to follow its instructions and procedures;
VI.be using effective contraception if a sexually active woman of a childbearing age;
VII.be able to speak, read, write, and understand their national language;
VIII.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);
IX.Participants will be required to nominate a current treating physician prior to randomization.
; I.Aged 18-65 years;
II.Have a DSM-V diagnosis of bipolar disorder I or II, or bipolar disorder not elsewhere classified (NEC);
III.Currently be in a major depressive episode on Structured Clinical Interview for DSM Disorders (SCID-5-RV);
IV.Score greater than or equal to 20 on the Montgomery Åsberg Depression Rating Scale (MADRS);
V.have the capacity to consent to the study and to follow its instructions and procedures;
VI.be using effective contraception if a sexually active woman of a childbearing age;
VII.be able to speak, read, write, and understand their national language;
VIII.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);
IX.Participants will be required to nominate a current treating physician prior to randomization.

Exclusion Criteria

I.have a known or suspected active systemic medical disorder;
II.have a primary clinical diagnosis of another disorder such as borderline personality disorder, assessed using the SCID-5-RV;
III.have a diagnosis of another psychotic disorder and/or current substance use disorder, assessed using the SCID-5-RV;
IV.be undergoing electroconvulsive or transcranial magnetic stimulation therapy;
V.have contraindications or intolerance or allergy to trimetazidine or any of the trial preparations;
VI.have a concurrent enrolment in another psychiatric clinical trial;
VII.are pregnant or lactating (participants will be requested to conduct a urine pregnancy test if sexually active and of child-bearing age);
VIII.Inability to comply with either the requirements of informed consent or the treatment protocol;
IX.Any history of renal disease/impairment, Parkinson’s disease, restless legs syndrome or other movement disorders.
; I.have a known or suspected active systemic medical disorder;
II.have a primary clinical diagnosis of another disorder such as borderline personality disorder, assessed using the SCID-5-RV;
III.have a diagnosis of another psychotic disorder and/or current substance use disorder, assessed using the SCID-5-RV;
IV.be undergoing electroconvulsive or transcranial magnetic stimulation therapy;
V.have contraindications or intolerance or allergy to trimetazidine or any of the trial preparations;
VI.have a concurrent enrolment in another psychiatric clinical trial;
VII.are pregnant or lactating (participants will be requested to conduct a urine pregnancy test if sexually active and of child-bearing age);
VIII.Inability to comply with either the requirements of informed consent or the treatment protocol;
IX.Any history of renal disease/impairment, Parkinson’s disease, restless legs syndrome or other movement disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of mood symptoms, measured using Montgomery-Åsberg Depression Rating Scale (MADRS).[ Conducted at all trial visits - Baseline (week 0 - pre-intervention) and Weeks 2, 4, and 8 post-intervention commencement. Week 8 is the primary endpoint.];Change in severity of mood symptoms, measured using Montgomery-Åsberg Depression Rating Scale (MADRS).[ Conducted at all trial visits - Baseline (week 0 - pre-intervention) and Weeks 2, 4, and 8 post-intervention commencement. Week 8 is the primary endpoint.]