The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Sertraline HCl; I-123-ADAM SPECT
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.; The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Objectives:

        1. 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

        2. To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for
           assisting in detecting MDD

        3. To evaluate the relationship between basal HAMD score and basal SERT availability for
           MDD subjects

        4. To evaluate the relationship between basal HAMD somatic subscale score and basal SERT
           availability for MDD subjects

        5. To evaluate the relationship between change of SERT availability and change of HAMD
           score for MDD patients being treated with Sertraline HCl
    

Eligibility criteria:

        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