Major Depressive Disorder Clinical Trial
— STAPMDDTDMOfficial 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
Verified date | December 2017 |
Source | Tri-Service General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 37 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital | Institute of Nuclear Energy Research, Taiwan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | 6 weeks (The Healthy control Group only had the scanning at baseline) | |
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. | 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. | assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A |