xml: <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/NCT05972798</url>
    </required_header>
    <id_info>
      <org_study_id>201701653B0</org_study_id>
      <nct_id>NCT05972798</nct_id>
    </id_info>
    <brief_title>Exploration of the Potential Mechanisms of n-3 Fatty Acids Supplementation in Depression and Cognitive Function in Patients With Late-life Depression</brief_title>
    <official_title>Exploration of the Potential Mechanisms of n-3 Fatty Acids Supplementation in Depression and Cognitive Function in Patients With Late-life Depression by Using Multi-modal Neuroimaging Methods</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chang Gung Memorial Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Depression in the elderly causes considerable distress, disability, and loss of life. The&#xD;
        accelerating aging boom is accentuating the importance of addressing late life depression&#xD;
        (LLD). Extensive efforts in searching for effective and safety treatment yielded&#xD;
        unsatisfactory results. Among the multiple agents in LLD treatment, long-chain&#xD;
        polyunsaturated omega-3 fatty acids (omega-3 PUFA) stands out as an interesting compound as&#xD;
        it addressed two main features in LLD, depressive mood and cognitive function. However, how&#xD;
        it affects the brain remains unknown. Therefore, in an on-going double-blind randomized&#xD;
        placebo-controlled study using 48 weeks omega-3 PUFA supplement in LLD treatment, we plan to&#xD;
        perform two MRI scans (pre-treatment and post-treatment), in an effort to understand the&#xD;
        unique neurobiology of omega-3 PUFA in the treatment of LLD. Along the trial,&#xD;
        neuropsychological function and associated inflammatory markers were also collected.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Depression in the elderly causes considerable distress, disability, and loss of life. The&#xD;
        accelerating aging boom is accentuating the importance of addressing late life depression&#xD;
        (LLD).Extensive efforts in searching for effective and safety treatment yielded&#xD;
        unsatisfactory results.Among the multiple agents in LLD treatment, long-chain polyunsaturated&#xD;
        omega-3 fatty acids(omega-3 PUFA) stands out as an interesting compound as it addressed two&#xD;
        main features in LLD,depressive mood and cognitive function. However, how it affects the&#xD;
        brain remains unknown.Therefore, in an on-going double-blind randomized placebo-controlled&#xD;
        study using 48 weeks omega-3 PUFA supplement in LLD treatment, we plan to perform two MRI&#xD;
        scans (pre-treatment and post-treatment), in an effort to understand the unique neurobiology&#xD;
        of omega-3 PUFA in the treatment of LLD. Along the trial, neuropsychological function and&#xD;
        associated inflammatory markers were also collected.&#xD;
  &#xD;
        From past study, what separates LLD from mid-life depression lying in two key features that&#xD;
        distinguish the brain in the elderly versus young individuals are cerebrovascular disease&#xD;
        (CVD) and neurodegeneration. We conceptualize the cognitive and emotional dysfunction in LLD&#xD;
        is obscured by the overlay of age-related brain abnormalities (e.g., white matter disease,&#xD;
        atrophy, neurodegeneration, etc.), which could be ameliorated by the supplement omega-3 PUFA.&#xD;
        We also expected functionally distinct brain regions (ex: amygdala in emotional processing,&#xD;
        hippocampus in memory encoding) will demonstrate between group differences in the activation&#xD;
        changes across trial. Moreover, all these neuroimaging changes may be mediated by concomitant&#xD;
        changes in inflammatory markers or neuropsychological profiles, validating the mechanism of&#xD;
        action in omega-3 PUFA as anti-inflammation.&#xD;
  &#xD;
        With the help with multi-modal neuroimaging approach, we can assimilate these findings into&#xD;
        an 'integrative neurobiological systems&quot;. We expect our findings would pin-point omega-3&#xD;
        PUFA's antidepressant effect in the brain level and solve its underlying biological&#xD;
        mechanism.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 25, 2018</start_date>
    <completion_date type="Actual">December 25, 2020</completion_date>
    <primary_completion_date type="Actual">September 25, 2018</primary_completion_date>
    <phase>N/A</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>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Loneliness UCLA</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>the severity of loneliness (the score range from 20-80,the lower score means worse)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ham D-17</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>the insight(the score range from 0-2,the higher score means worse)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Geriatric Depression Geriatric Depression Scale-15</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>the insight(the score range from 0-1,the higher score means worse)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>Sleep related scales</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Rating Scale for Anxiety (HAM-A)</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>the insight(the score range from 0-56,the higher score means worse)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Verbal Learning &amp; Memory</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>structural and functional connectivity</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>Brain MRI connectivity change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini-Mental State Examination (MMSE)</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>The test consists of questions that assess orientation to place and time, learning and memory, construction ability, attention, and calculation skill.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Brain-derived neurotrophic factor</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>Total BDNF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Free Brain-derived neurotrophic factor</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>Free BDNF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-6</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>IL-6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-1β</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>IL-1β</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-12</measure>
      <time_frame>Change from Baseline at 52 weeks</time_frame>
      <description>IL-12</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Late Life Depression</condition>
    <arm_group>
      <arm_group_label>Omega-3 fatty acids</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Age &gt; 60 years.&#xD;
  Previous major depressive disorder (MDD), single or recurrent.&#xD;
  Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Soybean oil</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Age &gt; 60 years.&#xD;
  Previous major depressive disorder (MDD), single or recurrent.&#xD;
  Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Omega-3 fatty acids</intervention_name>
      <description>2.2 g/d omega-3 PUFAs (1.2g EPA and 1g DHA per day) in patients with LLD</description>
      <arm_group_label>Omega-3 fatty acids</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Soybean oil</intervention_name>
      <description>Soybean oil in patients with LLD</description>
      <arm_group_label>Soybean oil</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt; 60 years.&#xD;
  &#xD;
            2. Previous major depressive disorder (MDD), single or recurrent.&#xD;
  &#xD;
            3. Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton&#xD;
               Depression Rating Scale (HAMD-17) less than 10&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Inability to provide informed consent.&#xD;
  &#xD;
            2. Depressive symptoms severe enough (i.e., HAMD-17 &gt;= 10) at the baseline.&#xD;
  &#xD;
            3. Dementia, as defined by MMSE &lt; 24 and clinical evidence of dementia.&#xD;
  &#xD;
            4. Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective&#xD;
               disorder, schizophreniform disorder, delusional disorder, or current psychotic&#xD;
               symptoms.&#xD;
  &#xD;
            5. Abuse of or dependence on alcohol or other substances within the past 3 months, and&#xD;
               confirmed by study physician interview.&#xD;
  &#xD;
            6. High risk for suicide (e.g., active SI and/or current/recent intent or plan) AND&#xD;
               unable to be managed safely in the clinical trial (e.g., unwilling to be&#xD;
               hospitalized). Urgent psychiatric referral will be made in these cases.&#xD;
  &#xD;
            7. Non-correctable clinically significant sensory impairment (i.e., cannot hear well&#xD;
               enough to cooperate with interview).&#xD;
  &#xD;
            8. Unstable medical illness, including delirium, uncontrolled diabetes mellitus,&#xD;
               hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that&#xD;
               are not under medical management. This will be determined based on information from&#xD;
               the patient's personal physician and study physician's clinical judgment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Che-min Lin</name>
        <address>
          <city>Keelung</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>January 2018</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>elderly depression</keyword>
    <keyword>long-chain polyunsaturated omega-3 fatty acids</keyword>
    <keyword>cognitive function</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972798
  org study id: 201701653B0
  nct id: NCT05972798
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Depression in the elderly causes considerable distress, disability, and loss of life. The
        accelerating aging boom is accentuating the importance of addressing late life depression
        (LLD). Extensive efforts in searching for effective and safety treatment yielded
        unsatisfactory results. Among the multiple agents in LLD treatment, long-chain
        polyunsaturated omega-3 fatty acids (omega-3 PUFA) stands out as an interesting compound as
        it addressed two main features in LLD, depressive mood and cognitive function. However, how
        it affects the brain remains unknown. Therefore, in an on-going double-blind randomized
        placebo-controlled study using 48 weeks omega-3 PUFA supplement in LLD treatment, we plan to
        perform two MRI scans (pre-treatment and post-treatment), in an effort to understand the
        unique neurobiology of omega-3 PUFA in the treatment of LLD. Along the trial,
        neuropsychological function and associated inflammatory markers were also collected.
  Depression in the elderly causes considerable distress, disability, and loss of life. The
        accelerating aging boom is accentuating the importance of addressing late life depression
        (LLD).Extensive efforts in searching for effective and safety treatment yielded
        unsatisfactory results.Among the multiple agents in LLD treatment, long-chain polyunsaturated
        omega-3 fatty acids(omega-3 PUFA) stands out as an interesting compound as it addressed two
        main features in LLD,depressive mood and cognitive function. However, how it affects the
        brain remains unknown.Therefore, in an on-going double-blind randomized placebo-controlled
        study using 48 weeks omega-3 PUFA supplement in LLD treatment, we plan to perform two MRI
        scans (pre-treatment and post-treatment), in an effort to understand the unique neurobiology
        of omega-3 PUFA in the treatment of LLD. Along the trial, neuropsychological function and
        associated inflammatory markers were also collected.
  
        From past study, what separates LLD from mid-life depression lying in two key features that
        distinguish the brain in the elderly versus young individuals are cerebrovascular disease
        (CVD) and neurodegeneration. We conceptualize the cognitive and emotional dysfunction in LLD
        is obscured by the overlay of age-related brain abnormalities (e.g., white matter disease,
        atrophy, neurodegeneration, etc.), which could be ameliorated by the supplement omega-3 PUFA.
        We also expected functionally distinct brain regions (ex: amygdala in emotional processing,
        hippocampus in memory encoding) will demonstrate between group differences in the activation
        changes across trial. Moreover, all these neuroimaging changes may be mediated by concomitant
        changes in inflammatory markers or neuropsychological profiles, validating the mechanism of
        action in omega-3 PUFA as anti-inflammation.
  
        With the help with multi-modal neuroimaging approach, we can assimilate these findings into
        an 'integrative neurobiological systems". We expect our findings would pin-point omega-3
        PUFA's antidepressant effect in the brain level and solve its underlying biological
        mechanism.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Loneliness UCLA
  time frame: Change from Baseline at 52 weeks
  description: the severity of loneliness (the score range from 20-80,the lower score means worse)
  measure: Ham D-17
  time frame: Change from Baseline at 52 weeks
  description: the insight(the score range from 0-2,the higher score means worse)
  measure: Geriatric Depression Geriatric Depression Scale-15
  time frame: Change from Baseline at 52 weeks
  description: the insight(the score range from 0-1,the higher score means worse)
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: Change from Baseline at 52 weeks
  description: Sleep related scales
  measure: Hamilton Rating Scale for Anxiety (HAM-A)
  time frame: Change from Baseline at 52 weeks
  description: the insight(the score range from 0-56,the higher score means worse)
  measure: Verbal Learning & Memory
  time frame: Change from Baseline at 52 weeks
  description: Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
  measure: structural and functional connectivity
  time frame: Change from Baseline at 52 weeks
  description: Brain MRI connectivity change
  measure: Mini-Mental State Examination (MMSE)
  time frame: Change from Baseline at 52 weeks
  description: The test consists of questions that assess orientation to place and time, learning and memory, construction ability, attention, and calculation skill.
  measure: Total Brain-derived neurotrophic factor
  time frame: Change from Baseline at 52 weeks
  description: Total BDNF
  measure: Free Brain-derived neurotrophic factor
  time frame: Change from Baseline at 52 weeks
  description: Free BDNF
  measure: Interleukin-6
  time frame: Change from Baseline at 52 weeks
  description: IL-6
  measure: Interleukin-1β
  time frame: Change from Baseline at 52 weeks
  description: IL-1β
  measure: Interleukin-12
  time frame: Change from Baseline at 52 weeks
  description: IL-12
  arm group label: Omega-3 fatty acids
  arm group type: Experimental
  description: Age > 60 years.
  Previous major depressive disorder (MDD), single or recurrent.
  Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10
  arm group label: Soybean oil
  arm group type: Placebo Comparator
  description: Age > 60 years.
  Previous major depressive disorder (MDD), single or recurrent.
  Mood is relatively stable for at least 3 weeks and the score of 17-item Hamilton Depression Rating Scale (HAMD-17) less than 10
  intervention type: Other
  intervention name: Omega-3 fatty acids
  description: 2.2 g/d omega-3 PUFAs (1.2g EPA and 1g DHA per day) in patients with LLD
  arm group label: Omega-3 fatty acids
  intervention type: Other
  intervention name: Soybean oil
  description: Soybean oil in patients with LLD
  arm group label: Soybean oil
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No