<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210962</url>
  </required_header>
  <id_info>
    <org_study_id>N N402 243435</org_study_id>
    <nct_id>NCT02210962</nct_id>
  </id_info>
  <brief_title>Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia</brief_title>
  <acronym>OFFER</acronym>
  <official_title>Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lodz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lodz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is accumulating experimental evidence to suggest the role of essential fatty acids&#xD;
      (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to&#xD;
      be dysfunctional on early stages of schizophrenia, according to neurodevelopmental&#xD;
      hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich&#xD;
      diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular&#xD;
      importance at the beginning of the illness. As a relatively safe option, EFA supplementation&#xD;
      would be a preferable add on therapy in treating individuals with a first episode of&#xD;
      schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up&#xD;
      studies of EFA supplementation in FES patients were carried out. The demonstration of the&#xD;
      efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would&#xD;
      be a strong basis for further studies and prescribing EFAs for a large population of patients&#xD;
      who are in the early stages of that debilitating illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.</measure>
    <time_frame>8 and 26 weeks of supplementation</time_frame>
    <description>The Positive and Negative Syndrome Scale [64] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse</measure>
    <time_frame>26 weeks intervention plus 26 weeks observation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PANSS total, positive, negative and general psychopathology subscales</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calgary Depression Scale for Schizophrenia (CDSS)</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Functioning (GAF)</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus</measure>
    <time_frame>Baseline, 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance using composite battery of neuropsychologic tests</measure>
    <time_frame>Baseline, 8 and 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Niacin Flush Skin Test</measure>
    <time_frame>Baseline, 8 and 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects profile according to self-prepared questionnaire</measure>
    <time_frame>Baseline, 4, 8, 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphocyte telomerase activity</measure>
    <time_frame>Baseline, 8 and 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Equivalent doses of antipsychotics used</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grey matter volume: a voxel based structural MRI assessment</measure>
    <time_frame>Baseline, 8 and 26 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma cholesterol and Triglycerides</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting glucose levels</measure>
    <time_frame>Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>essential fatty acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental treatment is a food supplement containing fish oil. The daily dose of 4 capsules provides 1320 mg of eicosapentaenoic acid and 880 mg of docosahexaenoic acid, 26 weeks intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>olive oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>essential fatty acids</intervention_name>
    <description>Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)</description>
    <arm_group_label>essential fatty acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>olive oil</intervention_name>
    <description>Yellow capsules containing olive oil (placebo)</description>
    <arm_group_label>olive oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with schizophrenia using Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, fourth edition (DSM-IV) criteria&#xD;
&#xD;
          -  Patients aged between 16-35 years&#xD;
&#xD;
          -  Signed informed consent (parallel parents consent for individuals under 18 years of&#xD;
             age)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients taking fish oil supplements (a washout period of 6 months is required)&#xD;
&#xD;
          -  Patients diagnosed with epilepsy or suffering from epileptic seizures&#xD;
&#xD;
          -  Patients receiving anticoagulant medication e.g., Warfarin&#xD;
&#xD;
          -  Patients receiving psychotherapy&#xD;
&#xD;
          -  Chronic somatic diseases&#xD;
&#xD;
          -  Psychoactive substance dependence&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Mental retardation or diagnosed organic brain injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz P Pawełczyk, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Affective and Psychotic Disorders Medical University of Lodz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Affective and Psychotic Disorders Medical University of Lodz</name>
      <address>
        <city>Lodz</city>
        <zip>92216</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>February 16, 2015</last_update_submitted>
  <last_update_submitted_qc>February 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lodz</investigator_affiliation>
    <investigator_full_name>Tomasz Pawelczyk</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>early psychosis</keyword>
  <keyword>chronic schizophrenia</keyword>
  <keyword>first episode psychosis</keyword>
  <keyword>omega-3 and omega-6 essential fatty acids</keyword>
  <keyword>relapse prevention</keyword>
  <keyword>efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210962
org study id: N N402 243435
nct id: NCT02210962
lead sponsor: 
has dmc: Yes
There is accumulating experimental evidence to suggest the role of essential fatty acids
      (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to
      be dysfunctional on early stages of schizophrenia, according to neurodevelopmental
      hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich
      diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular
      importance at the beginning of the illness. As a relatively safe option, EFA supplementation
      would be a preferable add on therapy in treating individuals with a first episode of
      schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up
      studies of EFA supplementation in FES patients were carried out. The demonstration of the
      efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would
      be a strong basis for further studies and prescribing EFAs for a large population of patients
      who are in the early stages of that debilitating illness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
time frame: 8 and 26 weeks of supplementation
description: The Positive and Negative Syndrome Scale [64] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.
measure: Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse
time frame: 26 weeks intervention plus 26 weeks observation
measure: PANSS total, positive, negative and general psychopathology subscales
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: Calgary Depression Scale for Schizophrenia (CDSS)
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: Clinical Global Impression (CGI)
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: Global Assessment of Functioning (GAF)
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
measure: A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus
time frame: Baseline, 26 weeks
measure: Cognitive performance using composite battery of neuropsychologic tests
time frame: Baseline, 8 and 26 weeks
measure: Niacin Flush Skin Test
time frame: Baseline, 8 and 26 weeks
measure: Side effects profile according to self-prepared questionnaire
time frame: Baseline, 4, 8, 26
measure: Lymphocyte telomerase activity
time frame: Baseline, 8 and 26 weeks
measure: Equivalent doses of antipsychotics used
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
measure: Grey matter volume: a voxel based structural MRI assessment
time frame: Baseline, 8 and 26 weeks
measure: Plasma cholesterol and Triglycerides
time frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Blood pressure
time frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Body mass index (BMI)
time frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Waist circumference
time frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
measure: Fasting glucose levels
time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
arm group label: essential fatty acids
arm group type: Experimental
description: The experimental treatment is a food supplement containing fish oil. The daily dose of 4 capsules provides 1320 mg of eicosapentaenoic acid and 880 mg of docosahexaenoic acid, 26 weeks intervention
arm group label: olive oil
arm group type: Placebo Comparator
description: Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention
intervention type: Dietary Supplement
intervention name: essential fatty acids
description: Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
arm group label: essential fatty acids
intervention type: Dietary Supplement
intervention name: olive oil
description: Yellow capsules containing olive oil (placebo)
arm group label: olive oil
criteria: 
gender: All
minimum age: 16 Years
maximum age: 35 Years
healthy volunteers: No
last name: Tomasz P Pawełczyk, MD, PhD
role: Principal Investigator
affiliation: Department of Affective and Psychotic Disorders Medical University of Lodz
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lodz
investigator full name: Tomasz Pawelczyk
investigator title: Assistant Professor
mesh term: Schizophrenia