drugset / Trial / NCT01078870
Trial for Antidepressant Treatment for Negative Symptom of Schizophrenia With NRG1 Risk Genotype
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 30 mg | — |
| Subject | Duloxetine | Small molecule | 60 mg | — |
| Subject | Escitalopram | Small molecule | 10 mg | — |
| Subject | Escitalopram | Small molecule | 20 mg | — |