Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD (STAPMDDTDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Major Depressive Disorder
Interventions Drug: Sertraline HCl
Other: I-123-ADAM SPECT
Enrollment 37
Recruitment Details The recruitment period was from Oct-07-2011 to Nov-28-2012. The recruitment site was a psychiatric outpatient in a medical center.
Pre-assignment Details

The treatment group:

No significant events in the study that occur after participant enrollment.

The healthy control group:

No significant events in the study that occur after participant enrollment.

Arm/Group Title Treatment Group Healthy Control Group
Hide Arm/Group Description

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.

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.

I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.

All healthy subjects had only basal I-123-ADAM SPECT scanning
Period Title: Overall Study
Started 20 17
Completed 20 17
Not Completed 0 0
Arm/Group Title Treatment Group Healthy Control Group Total
Hide Arm/Group Description

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.

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.

I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.

All healthy subjects (N=17) had only basal I-123-ADAM SPECT scanning. Total of all reporting groups
Overall Number of Baseline Participants 20 17 37
Hide Baseline Analysis Population Description
The treatment group received I-123-ADAM SPECT scanning before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. All healthy subjects had only basal I-123-ADAM SPECT.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 17 participants 37 participants
38.15  (12.35) 36.35  (12.72) 37.32  (12.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 17 participants 37 participants
Female
12
  60.0%
10
  58.8%
22
  59.5%
Male
8
  40.0%
7
  41.2%
15
  40.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 17 participants 37 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
20
 100.0%
17
 100.0%
37
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Taiwan Number Analyzed 20 participants 17 participants 37 participants
20
 100.0%
17
 100.0%
37
 100.0%
Hamilton Depression Rating Scale (HAMD) total score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 17 participants 37 participants
22.90
(18 to 30)
NA [2] 
(NA to NA)
22.90
(18 to 30)
[1]
Measure Description: 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. The patient is rated by a clinician on 17 items scored either on a 3-point or 5-point Likert-type scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.
[2]
We did not measure HAMD scores of Healthy control group.
serotonin transporter (SERT) binding potential over right basal ganglion   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 20 participants 17 participants 37 participants
0.52  (0.28) 0.94  (1.32) 0.68  (0.86)
[1]
Measure Description: Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region (right basal ganglion) - cerebellum) / cerebellum)
1.Primary Outcome
Title The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
Hide Description Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)
Time Frame 6 weeks (The Healthy control Group only had the scanning at baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.
Arm/Group Title Treatment Group
Hide Arm/Group Description:

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.

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.

I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: a ratio of target region to background
0.34  (0.26)
2.Secondary Outcome
Title Hamilton Depression Rating Scale (HAM-D) Total Scores
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
The subjects with major depressive disorder were assessed with Hamilton Depression Rating Scale (HAM-D) before and after 6 weeks of Sertraline HCl treatment.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.25  (4.01)
3.Secondary Outcome
Title Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
Hide Description 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.
Time Frame assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants in the Intention -to-treatment group completed the study.
Arm/Group Title Treatment Group Healthy Control Group
Hide Arm/Group Description:

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.

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.

I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.

All healthy subjects had only basal I-123-ADAM SPECT scanning.
Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.52  (2.76) 0.88  (1.96)
Time Frame 6 weeks
Adverse Event Reporting Description The healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments and were only monitored for adverse events at baseline.
 
Arm/Group Title Treatment Group Healthy Control Group
Hide Arm/Group Description

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.

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.

I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.

All healthy subjects had only basal I-123-ADAM SPECT scanning.
All-Cause Mortality
Treatment Group Healthy Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group Healthy Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Group Healthy Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/17 (0.00%)    
Eye disorders     
conjunctivitis *  1/20 (5.00%)  1 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Chin-bin Yeh
Organization: Tri-Service General Hospital, National Defense Medical center
Phone: 886-2-87923311 ext 17387
EMail: chinbinyeh@gmail.com
Layout table for additonal information
Responsible Party: Chin-Bin Yeh, MD, PhD, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02473783     History of Changes
Other Study ID Numbers: INEI-1A20090409
First Submitted: June 11, 2015
First Posted: June 17, 2015
Results First Submitted: August 15, 2017
Results First Posted: December 21, 2017
Last Update Posted: January 19, 2018