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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tri-Service General Hospital
• Collaborator: Institute of Nuclear Energy Research, Taiwan
• Treatments: Serotonin; Sertraline

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