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Table 1 Schedule of the study visits and planned assessments in OFFER trial

From: Omega-3 fatty acids in first-episode schizophrenia - a randomized controlled study of efficacy and relapse prevention (OFFER): rationale, design, and methods

ID Variable Study visits V1 V2 V3 V4 V5 V6 V7 V8 V9
   Week 0 1 2 4 6 8 16 26 52
1 Clinical measures PANSS X X X X X X X X X
CGI-S X X X X X X X X X
CGI-I X X X X X X X X X
CDSS X X X X X X X X X
GAF X X X X X X X X X
2 Insight questionnaire “My thoughts and feelings” X      X   X X
3 Prostaglandin synthesis (PGD2, PGE2) Niacin flush skin test X      X   X  
4 Cognitive function tests: Working memory and Executive functions TMT Part A and B, and their alternate forms, i.e. Part C, D and Digit Span Forward and Backward X      X   X  
Verbal memory CVLT X X X
Visual memory BVRT X X X
Abstract thinking Halstead Category Test X X X
Verbal fluency Semantic and Phonological X X X
5 Magnetic Resonance Imaging Grey matter thickness - VBM X        X  
Fractional anisotropy – DTI X X
6 Oxidative stress Isoprostane 8-epi-PGF2alpha (plasma) X      X   X  
Antioxidative defense Total plasma antioxidative capacity X X X
7 Neuronal plasticity Plasma BDNF concentration X      X   X  
8 Dietary questionnaire Diet history questionnaire X         
9 Metabolic syndrome traits Plasma lipid profile X      X   X X
(biochemical assessments) Fasting Blood Glucose level X X X X
10 Metabolic syndrome traits Body weight X X X X X X X X X
Waist circumference X X X X X X X X X
(clinical measures) Blood pressure X X X X X X X X X
  1. Abbreviations: PANSS – Positive and Negative Syndrome Scale, CGI-S - Clinical Global Impressions - Severity, CGI-I - Clinical Global Impressions - Improvement, CDSS - Calgary Depression Scale for Schizophrenia, GAF – Global Assessment of Functioning, PGD2 – Prostaglandin D2, PGE2 - Prostaglandin E2, TMT – Trail Making Test Part, CVLT – California Verbal Learning Test, BVRT - Benton Visual Retention Test , VBM – Voxel Based Morphometry, DTI –Diffusion tensor Imaging, 8epiPGF2alpha – plasma concentration of prostaglandin 8-epi-F-2alpha, BDNF – plasma concentration of brain derived neurotrophic factor.