Phase 2 Completed N=37 Other

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

Source: ClinicalTrials.gov NCT02473783 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcomePrimary: The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed) — 0.34 a ratio of target region to background

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

Outcome Measures

Outcome	Result	p-value
PRIMARY The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)	0.34	—
SECONDARY Hamilton Depression Rating Scale (HAM-D) Total Scores	5.25	—
SECONDARY Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution	1.52; 0.88	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02473783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.