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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
Sponsor:
Collaborator:
Institute of Nuclear Energy Research, Taiwan
Information provided by (Responsible Party):
Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE June 17, 2015
Results First Submitted Date  ICMJE August 15, 2017
Results First Posted Date  ICMJE December 21, 2017
Last Update Posted Date January 19, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
  • Efficacy Assessments [ Time Frame: 6 weeks ]
    The change of SERT availability from baseline to week 6 in the treatment group
  • The applicability of detecting MDD by SERT availability [ Time Frame: -5~0 days, the baseline I-123-ADAM SPECT scan was performed before the medication treatment ]
    The difference of SERT availability between subjects with MDD before treatment and healthy subjects
Change History Complete list of historical versions of study NCT02473783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
Efficacy Assessments [ Time Frame: 6 weeks ]
The change of HAM-D scores from baseline to week 6 in the treatment group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 16, 2015)
  • Safety Assessments - Pain Scores as measured by the Visual Analog Scale for the tolerability [ Time Frame: -5~0 days, and 6 weeks ±5 days (I-123-ADAM SPECT scan) ]
    Pain Scores as measured by the Visual Analog Scale for the tolerability
  • Safety Assessments - Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 weeks ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability throughout the study.
 
Descriptive Information
Brief Title  ICMJE The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Sertraline HCl
  • Other: I-123-ADAM SPECT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2017)
37
Original Actual Enrollment  ICMJE
 (submitted: June 16, 2015)
55
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02473783
Other Study ID Numbers  ICMJE INEI-1A20090409
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital
Study Sponsor  ICMJE Tri-Service General Hospital
Collaborators  ICMJE Institute of Nuclear Energy Research, Taiwan
Investigators  ICMJE
Principal Investigator: Chin-Bin Yeh, M.D., Ph.D. Tri-Service General Hospital
PRS Account Tri-Service General Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP