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| Name | Class |
|---|---|
| National Atomic Research Institute, Taiwan | OTHER |
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Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline HCl | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed) | Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum) | 6 weeks (The Healthy control Group only had the scanning at baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) Total Scores | 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. |
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Inclusion Criteria:
- For MDD subjects
For healthy subjects
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Bin Yeh, M.D., Ph.D. | Tri-Service General Hospital (TSGH) | Principal Investigator |
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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.
The recruitment period was from Oct-07-2011 to Nov-28-2012. The recruitment site was a psychiatric outpatient in a medical center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Healthy Control Group | All healthy subjects had only basal I-123-ADAM SPECT scanning |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed) | Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum) | 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. | Posted | Mean | Standard Deviation | a ratio of target region to background | 6 weeks (The Healthy control Group only had the scanning at baseline) |
|
6 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctivitis | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chin-bin Yeh | Tri-Service General Hospital, National Defense Medical center | 886-2-87923311 | 17387 | chinbinyeh@gmail.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
| I-123-ADAM SPECT | Other | The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection. |
|
| 6 weeks |
| Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution | 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. | assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan) |
| BG001 | Healthy Control Group | All healthy subjects (N=17) had only basal I-123-ADAM SPECT scanning. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hamilton Depression Rating Scale (HAMD) total score | 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. | Mean | Full Range | units on a scale |
|
| serotonin transporter (SERT) binding potential over right basal ganglion | Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region (right basal ganglion) - cerebellum) / cerebellum) | Mean | Standard Deviation | ratio |
|
|
|
| Secondary | Hamilton Depression Rating Scale (HAM-D) Total Scores | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution | 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. | All the participants in the Intention -to-treatment group completed the study. | Posted | Mean | Standard Deviation | units on a scale | assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan) |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Healthy Control Group | All healthy subjects had only basal I-123-ADAM SPECT scanning. | 0 | 17 | 0 | 17 |
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| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |