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The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD (STAPMDDTDM)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sertraline HCl
I-123-ADAM SPECT
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Major Depressive Disorder

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- For MDD subjects

  1. Subject meets the DSM-IV criteria for MDD
  2. Subject has a minimum score of 18 on the 17-item HAMD total score
  3. Subject has a minimum score of 2 on item 1, depressed mood, of HAMD
  4. Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives

For healthy subjects

  1. Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination
  2. Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study

Exclusion Criteria:

  1. Subject with history of any co-morbid neuropsychiatric disease
  2. Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication
  3. Subject with history of alcohol or substance dependence or abuse
  4. Subject with allergic history to the investigational products
  5. Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study
  6. Subject with malignancy within past 5 years
  7. Subject with any diseases judged by investigators as inappropriate for this study
  8. Female subject being pregnant, nursing, or lactating
  9. Female subject of childbearing potential not using a medically acceptable form of birth control
  10. Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations
  11. Subject participated in any investigational drug trial within 4 weeks before entering this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

    The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.

    Outcomes

    Primary Outcome Measures

    The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
    Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)

    Secondary Outcome Measures

    Hamilton Depression Rating Scale (HAM-D) Total Scores
    The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.
    Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
    Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome.

    Full Information

    First Posted
    June 11, 2015
    Last Updated
    December 20, 2017
    Sponsor
    Tri-Service General Hospital
    Collaborators
    Institute of Nuclear Energy Research, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02473783
    Brief Title
    The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD
    Acronym
    STAPMDDTDM
    Official Title
    An I-123-ADAM SPECT Imaging Study to Evaluate the Serotonin Transporter (SERT) Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Assisting in Detecting MDD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    November 2012 (Actual)
    Study Completion Date
    November 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tri-Service General Hospital
    Collaborators
    Institute of Nuclear Energy Research, Taiwan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: To evaluate the relationship between improvement of Hamilton Depression Rating Scale (HAMD) score and basal SERT availability (binding potential) for the prognosis of MDD subjects being treated with Sertraline HCl To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl
    Detailed Description
    Background: Serotonin transporter (SERT) plays an important role in the pathophysiology of psychiatric disorders such as anxiety and depression and is the primary target of the selective serotonin reuptake inhibitors (SSRIs) which are posited to exert their effect in treating psychiatric disorders aforementioned by this mechanism. I-123-ADAM is a selective radioligand for imaging SERT using SPECT. Research showed that it displayed an extremely high binding affinity to SERT sites. Previous literature also suggested the potential role of I-123-ADAM SPECT as useful in understanding how serotonin system affected depression. This study aims to evaluate the SERT availability by means of I-123-ADAM SPECT imaging study in drug-free subjects for prognosing MDD treatment and assisting in detecting MDD. Methods: We enrolled patients who had major depressive disorder but was free from prior antidepressant medication for at least 5 times of elimination half-lives and healthy controls. The patients with major depressive disorder (N=20) received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. All healthy subjects (N=17) had only basal I-123-ADAM SPECT. The relationship between improvement of depressive symptoms and basal SERT availability for the prognosis of MDD subjects being treated with Sertraline HCl will be analyzed. In addition, the association between the efficacy of treatment with Sertraline HCl and the change of SERT availability will also be investigated. The control group were selected in order to distinguish the difference of basal SERT binding potential of I-123-ADAM between healthy and MDD subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
    Intervention Type
    Drug
    Intervention Name(s)
    Sertraline HCl
    Other Intervention Name(s)
    Zoloft
    Intervention Description
    The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    I-123-ADAM SPECT
    Intervention Description
    The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
    Primary Outcome Measure Information:
    Title
    The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
    Description
    Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)
    Time Frame
    6 weeks (The Healthy control Group only had the scanning at baseline)
    Secondary Outcome Measure Information:
    Title
    Hamilton Depression Rating Scale (HAM-D) Total Scores
    Description
    The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.
    Time Frame
    6 weeks
    Title
    Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
    Description
    Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome.
    Time Frame
    assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - For MDD subjects Subject meets the DSM-IV criteria for MDD Subject has a minimum score of 18 on the 17-item HAMD total score Subject has a minimum score of 2 on item 1, depressed mood, of HAMD Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives For healthy subjects Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study Exclusion Criteria: Subject with history of any co-morbid neuropsychiatric disease Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication Subject with history of alcohol or substance dependence or abuse Subject with allergic history to the investigational products Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study Subject with malignancy within past 5 years Subject with any diseases judged by investigators as inappropriate for this study Female subject being pregnant, nursing, or lactating Female subject of childbearing potential not using a medically acceptable form of birth control Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations Subject participated in any investigational drug trial within 4 weeks before entering this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chin-Bin Yeh, M.D., Ph.D.
    Organizational Affiliation
    Tri-Service General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD

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