Overview

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

Status:
Unknown status
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Citalopram
Duloxetine Hydrochloride
Criteria
Inclusion Criteria:

1. aged between 18-65

2. meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition (DSM-IV) schizophrenia

3. the genotype of NRG1-P3 is the homozygous risk genotype (TT)

4. under second-generation antipsychotic treatment with relatively stable clinical status
(no change of prescribed medications during past 8 weeks and all symptom items in the
positive subscale of PANSS with score no more than 4)

5. having moderate to marked negative symptoms (scores between 4 to 6 in the items of N2,
emotional withdrawal, and N4, passivity/apathetic social withdrawal)

Exclusion Criteria:

1. lifetime diagnosis of schizoaffective disorder, bipolar affective disorder, and major
depressive disorder and the score of Hamilton Depression Rating Scale (HAM-D) is above
18

2. the genotype of NRG1-P3 is TC or CC

3. having any major systemic illness

4. receiving first-generation antipsychotics or already on antidepressants or
mood-stabilizing agents adjuvant

5. substance abuse in the past 6 months

6. pregnancy