The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD
Information source: Tri-Service General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Sertraline HCl (Drug); I-123-ADAM SPECT (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Tri-Service General Hospital Official(s) and/or principal investigator(s): Chin-Bin Yeh, M.D., Ph.D., Principal Investigator, Affiliation: Tri-Service General Hospital
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
Clinical Details
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 design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Efficacy AssessmentsThe applicability of detecting MDD by SERT availability
Secondary outcome: Efficacy Assessments
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=28) 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=27) 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2011
Last updated: June 16, 2015
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