CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Sertraline HCl +1 moredrug
Likely dose
Sertraline HCl 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02473783
NCT02473783Phase 2Completed
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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

Tri-Service General Hospital·interventional·Posted Jun 17, 2015·Updated Jan 19, 2018

In Brief

A Phase 2 clinical trial evaluating Sertraline HCl and I-123-ADAM SPECT for Major Depressive Disorder. Completed, enrolled 37 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
Countries--
CollaboratorsNational Atomic Research Institute, Taiwan

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2015
Enrollment StartOct 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.0 years ago

Interventions

Sertraline HCldrug

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 SPECTother

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