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

NCT02473783 | Completed Phase 2 Results

• 1 other identifier: INEI-1A20090409
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives:

1. 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. 2.To evaluate the SERT availability by means of I-123-ADAM SPECT imaging study for assisting in detecting MDD
3. 3.To evaluate the relationship between basal HAMD score and basal SERT availability for MDD subjects
4. 4.To evaluate the relationship between basal HAMD somatic subscale score and basal SERT availability for MDD subjects
5. 5.To evaluate the relationship between change of SERT availability and change of HAMD score for MDD patients being treated with Sertraline HCl

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hamilton Depression Rating Scale (HAM-D) Total Scores

  6 weeks

• Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution

  assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)

Study Arms (1)

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.

Drug: Sertraline HCl; Other: I-123-ADAM SPECT

Interventions

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.

Also known as: Zoloft

Treatment Group

I-123-ADAM SPECT OTHER

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

Treatment Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- For MDD subjects
• Subject meets the DSM-IV criteria for MDD
• Subject has a minimum score of 18 on the 17-item HAMD total score
• Subject has a minimum score of 2 on item 1, depressed mood, of HAMD
• Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives
• For healthy subjects
• 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
• Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study

You may not qualify if:

• Subject with history of any co-morbid neuropsychiatric disease
• Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication
• Subject with history of alcohol or substance dependence or abuse
• Subject with allergic history to the investigational products
• Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study
• Subject with malignancy within past 5 years
• Subject with any diseases judged by investigators as inappropriate for this study
• Female subject being pregnant, nursing, or lactating
• Female subject of childbearing potential not using a medically acceptable form of birth control
• 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
• Subject participated in any investigational drug trial within 4 weeks before entering this study

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• National Atomic Research Institute, Taiwan: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Chin-bin Yeh
• Organization: Tri-Service General Hospital, National Defense Medical center

chinbinyeh@gmail.com

886-2-87923311

Study Officials

• Chin-Bin Yeh, M.D., Ph.D.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Psychiatry

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 17, 2015
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 19, 2018
• Results First Posted: December 21, 2017

Record last verified: 2017-12