Table 1 Summary of measures

Written informed consent

√

Assessment of eligibility

√

MINI 7.0 to confirm MDD and other comorbid axis 1 disorders

√

Assessment of depression severity (HDRS-17)

√

Assessment of medication history in current depressive episode

√

Sociodemographic / Psychiatric and Medical History (including MSM)

√

Assessment of concomitant medication and non-pharmacological therapies

√

√

√

√

√

Clinician-rated assessment of clinical symptoms (MÅDRS, CGI)

√

√

√

√

Randomisation

√

Clinician-rated depression severity (including subtype: IDS-C)^b

√

√

Hypomanic checklist (HCL-16)^b

√

Assessment of side effects (FIBSER^b and PRISE)

√

√

√

Assessment of quality of life (EQ-5D)

√

√

√

√

Assessment of cognition (THINC-it^{a, b} and DSCT^b)

√

√

√

√

Weekly True Colours self-rated measures: QID-SR, WSAS, and trial medication status

√

√

√

√

√

Self-Rated clinical measures (ASRM^b, Maudsley VAS measures^b, GAD-7^b, SAPAS^b)

√

√

√

√

Assessment of costs (CSRI^b and employment status^b)

√

√

√

√

Treatment satisfaction (TSQM^b)

√

√

√

Adherence (baseline to antidepressant^b, follow up to trial medication)

√

√

√

√

Qualitative assessment of patient experience of True Colours^{a, b}

√

or √

or √

Physical health (weight, height, blood pressure, pulse rate, waist circumference)

√

√

√

√

Blood tests (FBC, U&Es, LFTs, TFT, glucose, lipids, calcium)^{a, b}

√

√

√

Lithium and quetiapine serum levels^{a, b}

√

√

BioResource genetic/cortisol/cytokine sample collection^{a, b}

√

√

√