E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037234 |
E.1.2 | Term | Psychosis |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether the addition of 120,000 IU monthly of vitamin D (cholecalciferol) supplement to standard treatments is more effective than placebo in improving outcomes (Positive And Negative Syndrome Scale Total score – PANSS) at six month follow-up in those with First Episode Psychosis. |
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E.2.2 | Secondary objectives of the trial |
To examine PANSS Total score and related subscores at 3 and 6 months, and a broader range of clinically-relevant outcomes based on Global Assessment of Function (GAF), the Calgary Depression Scale, cardiovascular risk markers and 25OHD vitamin D concentrations. We will examine primary and secondary outcomes in (a) all participants and (b) in a subgroup of patients with suboptimal vitamin D concentrations at baseline (except for the secondary outcome of 25 (OH) D concentrations which will examine in all participants. Tertiary Objective: To collect data on inflammatory/immune markers
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients within EIS and FEP inpatient units who meet the following criteria will be invited to participate in the study:
a. Aged between 18-65 years old including women of child-bearing age
b. Having a diagnosis of functional psychosis FEP defined according to ICD-10 criteria for psychosis (codes F20-29 and F30-33) c. Willing to agree to refrain from taking multivitamin or non-study vitamin D supplements (including cod liver oil) that exceed 400IU/day throughout the study.
d. Willing to give a blood vitamin D sample at baseline
e. Patients who are able and have given written informed consent. |
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E.4 | Principal exclusion criteria |
a) Known intolerance of Vitamin D2 or D3 or known allergy to any of the trial medications b) Those who are currently taking vitamin D supplements at a dose exceeding 400IU/day c) Those who have taken cardiac glycosides, calcium channel blockers or oral, intramuscular or intravenous corticosteroids , bendroflumethiazide, isoniazid or rifampicin in the past one month d) Known active tuberculosis, sarcoidosis, hypo or hyperparathyroidism, past or present nephrolithiasis(renal stones), suspected or diagnosed hepatic or renal dysfunction, any malignancy other than non-melanoma skin cancer not in remission for ≥ 3 years, calcium disorders e) Baseline corrected serum calcium > 2.6mmol/L f) Patients with known history of hypercalcaemia g) Pregnant or breast-feeding women and women planning a pregnancy h) Patients lacking the capacity to provide written informed consent i) Those who do not have sufficient English to complete the core assessments with the available assistance |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total PANSS score at 6 month follow-up |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Total PANNS score at 3 months PANSS Positive Scale sub score at 3 and 6 months PANSS Negative Scale sub score at 3 and 6 months PANSS General Psychopathology Scale sub score at 3 and 6 months Global Assessment of Function (GAF) at 6 months Calgary Depression Scale (CDS) at 6 months. Waist Circumference (cm) at 6 months BMI (kg/m2) at 6 months HbA1c (mmol/mol) at 6 months Total Cholesterol (mmol/L) at 6 months CRP (mg/L) at 6 months 250 (OH)D Concentrations at 6 months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patient's final follow up telephone call |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |