The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD (STAPMDDTDM)
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|ClinicalTrials.gov Identifier: NCT02473783|
Recruitment Status : Completed
First Posted : June 17, 2015
Results First Posted : December 21, 2017
Last Update Posted : January 19, 2018
- 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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Sertraline HCl Other: I-123-ADAM SPECT||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Treatment Group
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.
Drug: Sertraline HCl
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.
Other Name: Zoloft
Other: I-123-ADAM SPECT
The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
- The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed) [ Time Frame: 6 weeks (The Healthy control Group only had the scanning at baseline) ]Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region － cerebellum) / cerebellum)
- Hamilton Depression Rating Scale (HAM-D) Total Scores [ Time Frame: 6 weeks ]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 [ Time Frame: assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan) ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473783
|Principal Investigator:||Chin-Bin Yeh, M.D., Ph.D.||Tri-Service General Hospital|