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
Study type: Interventional
Phase: Phase 2

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
    

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.
    

Intervention name(s): Sertraline HCl; I-123-ADAM SPECT
Intervention type(s): Drug; Other
Intervention description(s): 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.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other