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| ID | Type | Description | Link |
|---|---|---|---|
| 01T-106 (Stanley M.R.I.,USA) |
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| Name | Class |
|---|---|
| Diakonhjemmet Hospital | OTHER |
| Stanley Medical Research Institute | OTHER |
| Laxdale Ltd | UNKNOWN |
| Scandinavian Society for Psychopharmacology |
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The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Objective:
Study the effect of adding Ethyl-EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Methods and material:
Design: Multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2 factorial, add-on clinical trial.
Sample:
Clinical assessments: Positive and Negative Syndrome Scale (PANSS) (main outcome variable). Self-report questionnaire. Adverse effects (UKURS). Neurocognitive assessment battery. Niacin skin flush test. General medical assessment.
Blood samples: RBC fatty acids, S-α-tocopherol, F2-isoprostane (kits), monocyte mRNA Phospholipase A22 (PLA2) Gr4a and 6a (RT-PCR method), RBC Gr4a PLA2 concentration (ELISA technique), a range of other biochemical tests.
Experimental treatment over 16 weeks: Ethyl-EPA 2 g/d or Placebo EPA and Vitamin E 364 mg/d + Vitamin C 1000 mg/d or Placebo Antioxidants
Statistics: Linear Mixed Model for longitudinal analyses of effects; other uni- and multivariate methods (SPSS 12.0 - PASW Statistics 18).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethyl EPA (active) and Vitamins E + C (active) | Experimental |
| |
| Ethyl EPA (active) and Vitamins E+C (placebo) | Experimental |
| |
| Ethyl EPA (placebo) and Vitamins E+C (active) | Experimental |
| |
| Ethyl EPA (placebo) and Vitamins E+C (placebo) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethyl-eicosapentaenoic acid (EPA) | Drug | Capsules, 2 g per day for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS)- Total | Baseline - 8 weeks - 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS Subscales Negative, Positive, General Psychopathology | Weeks 0, 8, 16 | |
| GLOBAL ASSESSMENT OF FUNCTIONING- Split Version (S-GAF) | (S-GAF)Symptom Scale (S-GAF)Function Scale | Weeks 0, 8, 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HÃ¥vard Bentsen, MD PhD | Aker University Hospital (-2004), Diakonhjemmet Hospital (2004-) | Study Director |
| Odd Lingjærde, MD PhD | University Hospital, Aker | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aker University Hospital | Oslo | 0320 | Norway |
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| UNKNOWN |
| Shipowner Emil Stray's legacy | UNKNOWN |
| Johanne and Einar Eilertsen's research fund | UNKNOWN |
| AstraZeneca | INDUSTRY |
| Solveig and Johan P. Sommer's foundation | UNKNOWN |
| Josef and Haldis Andresen's legacy | UNKNOWN |
| University of Oslo | OTHER |
| Norwegian University of Science and Technology | OTHER |
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|
| Vitamins E + C | Drug | RRR-alpha-tocopherol 392 mg + slow-release ascorbic acid 1000 mg per day, for 16 weeks |
|
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| Etyl EPA (placebo) | Other | Paraffin oil. Capsules, each 0.5 g. |
|
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| Vitamins E+C (placebo) | Other | Tablets containing dicalciumphosphate |
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| WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS | 5 scales | Weeks 0, 8, 16 |
| NIACIN SKIN FLUSH TEST | 2 concentrations of niacin | Weeks 0, 8, 16 |
| THE UKU SIDE EFFECT RATING SCALE (USERS) |
| Weeks 0,4,8,12,16 |
| SERIOUS ADVERSE EVENTS | Weeks 0,4,8,12,16 |
| CONCOMITANT ANTIPSYCHOTIC MEDICATION | Defined Daily Doses (ATC/WHO) | Weeks 0,4,8,12,16 |
| Kimura Recurring Recognition Figures Test | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Hopkins Verbal Learning Test. | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Continuous Performance Test | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Hopkins Verbal Learning Test | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Paced Auditory Serial Addition Test | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Stroop Test | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Digit Span | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| The Letter - Number Task | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0,16 |
| Semantic and Category Fluency | A sub-sample of patients. For logistic reasons, only some study sites could participate. | Weeks 0, 16 |
| Body Mass Index | Weeks 0, 16 |
| Blood pressure - systolic, diastolic | Weeks 0, 16 |
| Heart rate | Weeks 0, 16 |
| Albumin | Serum | Weeks 0, 16 |
| Urate | Serum | Weeks 0, 16 |
| Glucose | Serum - fasting | Weeks 0, 16 |
| Cholesterol | Serum - fasting | Weeks 0, 16 |
| Triglycerides | Serum - fasting | Weeks 0, 16 |
| Fatty acids in red blood cells | The concentrations of long-chain (C14-18) and very long-chain (C20-24)fatty acids in erythrocytes were measured. Fasting condition. We selected DGLA, AA, EPA, DHA, total omega-3 Polyunsaturated Fatty Acids (PUFA), total omega-6 PUFA, PUFA and LCPUFA (long-chain PUFA) as outcome measures. | Weeks 0, 16 |
| Alpha-tocopherol adjusted for [triglycerides]+[cholesterol]. | Serum | Weeks 0, 16 |
| Total antioxidant status | Serum | Weeks 0, 16 |
| Malondialdehyde | Also called "TBARS". Serum | Weeks 0, 16 |
| F2-isoprostane (8-epiPGF2-alpha) | Serum | Weeks 0, 16 |
| Cytosolic PLA2 group IV in red blood cells(ELISA method) | Omitted from stastical analyses because of problems with the pre-analytic procedure (treatment the of blood) |
| Gene expression of mRNA for Phospholipase A2 (PLA2) groups IVa and VIa in monocytes. | Whole blood | Weeks 0, 16 |
| Mean Corpuscular Haemoglobin Concentration (MCHC) | Whole blood | Weeks 0, 16 |
| Mean Corpuscular Volume (MCV) | Whole blood | Weeks 0, 16 |
| C- Reactive Protein (CRP) | Plasma | Weeks 0, 16 |
| Haemoglobin | Whole blood | Weeks 0, 16 |
| Leukocytes | Whole blood | Weeks 0, 16 |
| Calcium | Serum | Weeks 0, 16 |
| Sodium | Serum | Weeks 0, 16 |
| Potassium | Serum | Weeks 0, 16 |
| Ferritin | Serum | Weeks 0,16 |
| Free thyroxin (T4) | Serum | Weeks 0, 16 |
| Thyroid Stimulating Hormone (TSH) | Serum | Weeks 0, 16 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D003702 | Delusions |
| D006212 | Hallucinations |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C035276 | eicosapentaenoic acid ethyl ester |
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