Major Depressive Disorder Clinical Trial
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
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
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.
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