Time point | Screening | Baseline (Week 0) | Follow up | |||
---|---|---|---|---|---|---|
Weekly Assessments Weeks 0–52 | Week 8 (+ − 1 weeks) | Week 26 (+ − 2 weeks) | Week 52 (+ − 2 weeks) | |||
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 (FIBSERb and PRISE) |  |  |  | √ | √ | √ |
Assessment of quality of life (EQ-5D) |  | √ |  | √ | √ | √ |
Assessment of cognition (THINC-ita, b and DSCTb) |  | √ |  | √ | √ | √ |
Weekly True Colours self-rated measures: QID-SR, WSAS, and trial medication status |  | √ | √ | √ | √ | √ |
Self-Rated clinical measures (ASRMb, Maudsley VAS measuresb, GAD-7b, SAPASb) |  | √ |  | √ | √ | √ |
Assessment of costs (CSRIb and employment statusb) |  | √ |  | √ | √ | √ |
Treatment satisfaction (TSQMb) |  |  |  | √ | √ | √ |
Adherence (baseline to antidepressantb, follow up to trial medication) |  | √ |  | √ | √ | √ |
Qualitative assessment of patient experience of True Coloursa, 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 levelsa, b |  |  |  | √ |  | √ |
BioResource genetic/cortisol/cytokine sample collectiona, b |  | √ |  | √ |  | √ |