Table 1.
Summary of measures
| 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 | √ | √ | √ | |||
MINI 7.0 Mini International Neuropsychiatric Interview, Version 7.0, MDD major depressive disorder, HDRS Hamilton Depression Rating Scale – 17 items, MSM Maudsley Staging Method, MÅDRS Montgomery-Åsberg Depression Rating Scale, CGI Clinical Global Impressions, IDS-C Inventory of Depressive Symptomatology – Clinician Rated, HCL-16 Hypomanic Checklist – 16 items, FIBSER Frequency, Intensity and Burden of Side Effects Ratings, PRISE Patient Rated Inventory of Side Effects, EQ-5D EuroQol-5D health index, THINC-it THINC-it tool for cognitive dysfunction in Major Depressive Disorder, DSCT Digit Symbol Coding Test, WSAS Work and Social Adjustment Scale, ASRM Altman Self-Rating Mania Scale, VAS Visual Analogue Scale, GAD-7 Generalised Anxiety Disorder questionnaire – 7 items, SAPAS Standard Assessment of Personality: abbreviated Scale, CSRI Client Service Receipt Inventory, FBC Full blood count, U&Es Urea, electrolytes and creatinine, LFTS Liver function tests, TFT Thyroid function tests
a Optional and/or collected in a subset of participants
b Measures solely for tertiary and ancillary analyses