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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

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Sertraline HCl Other: I-123-ADAM SPECT Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473783


Sponsors and Collaborators
Tri-Service General Hospital
Institute of Nuclear Energy Research, Taiwan
Investigators
Principal Investigator: Chin-Bin Yeh, M.D., Ph.D. Tri-Service General Hospital

Responsible Party: Chin-Bin Yeh, MD, PhD, Director of Department of Psychiatry, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02473783     History of Changes
Other Study ID Numbers: INEI-1A20090409
First Posted: June 17, 2015    Key Record Dates
Results First Posted: December 21, 2017
Last Update Posted: January 19, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Serotonin
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists