Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419146
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2007-01-05
Brief Title:
Treatment of Schizophrenia With an Omega-3 Fatty Acid EPA and Antioxidants
Sponsor:
University Hospital Aker
Organization:
Oslo University Hospital
Study Overview
Official Title:
A Multicentre Placebo-controlled Trial of Eicosapentaenoic Acid EPA and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA andor Vitamins E C to antipsychotic drugs in younger patients with schizophrenia and related psychoses
Detailed Description:
Objective
Study the effect of adding Ethyl-EPA andor 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
Patients with schizophrenia schizoaffective disorder or schizophreniform disorder DSM-IV aged 18-40 years less than 15 years since first psychotic symptomsadmitted to a psychiatric department within the previous 21 days before screening speaks fluently a Scandinavian languagetreated with antipsychotics written informed consentno known allergy to trial agentsno substance dependence DSM-IVno warfarin currently or anamnestic indicators of impaired haemostasis Planned 200 patients Actually included 99 intent-to-treat patients
Healthy controls aged 18-40 yearsno mental disorder DSM-IV Included 20 persons
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 gd or Placebo EPA and Vitamin E 364 mgd Vitamin C 1000 mgd or Placebo Antioxidants
Statistics Linear Mixed Model for longitudinal analyses of effects other uni- and multivariate methods SPSS 120 - PASW Statistics 18
Study the effect of adding Ethyl-EPA andor 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
Patients with schizophrenia schizoaffective disorder or schizophreniform disorder DSM-IV aged 18-40 years less than 15 years since first psychotic symptomsadmitted to a psychiatric department within the previous 21 days before screening speaks fluently a Scandinavian languagetreated with antipsychotics written informed consentno known allergy to trial agentsno substance dependence DSM-IVno warfarin currently or anamnestic indicators of impaired haemostasis Planned 200 patients Actually included 99 intent-to-treat patients
Healthy controls aged 18-40 yearsno mental disorder DSM-IV Included 20 persons
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 gd or Placebo EPA and Vitamin E 364 mgd Vitamin C 1000 mgd or Placebo Antioxidants
Statistics Linear Mixed Model for longitudinal analyses of effects other uni- and multivariate methods SPSS 120 - PASW Statistics 18
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01T-106 Stanley MRIUSA | None | None | None |