drugset / Trial / NCT01078870

Trial for Antidepressant Treatment for Negative Symptom of Schizophrenia With NRG1 Risk Genotype

NCT01078870

Phase 4 Unknown 75 enrolled National Taiwan University Hospital
RandomizedParallel-groupTriple-blindDiagnostic

Summary

The project is a double-blind, randomized, placebo controlled clinical trial comparing 3 groups of schizophrenic subjects, who have no less than moderate degree of negative symptoms and carry the homozygous risk genotype (TT) of NRG1-P3, each group having 30 individuals, treated by add-on with escitalopram 10-20 mg/day, duloxetine 30-60 mg/day, and placebo. The treatment duration is 8 week. The investigators will evaluate the Positive and Negative Symptom Scale (PANSS) at baseline, Day 14, Day 28, Day 42, and Day 56. The primary outcome of interest will be the differences of averaged reduction of negative symptom scores among 3 groups and an average decrease of 2 or more in the negative symptoms will be indicated as improvement.

Timeline

Start
2010-02
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 30 mg
Subject Duloxetine Small molecule 60 mg
Subject Escitalopram Small molecule 10 mg
Subject Escitalopram Small molecule 20 mg

Indications