Schizophrenia Clinical Trial
— TANESNOfficial title:
A Double-blind, Randomized, Placebo Controlled Clinical Trial on Comparing Escitalopram and Duloxetine add-on for Negative Symptoms in Schizophrenic Subjects With Neuregulin-1 (NRG1) Risk Genotype
Verified date | February 2010 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome of interest will be the differences of averaged reduction of negative symptom scores among 3 groups compared by Analysis of Variance (ANOVA). | 2010/12 | No | |
Secondary | A decrease of 2 or more in the items of N2 or N4 will be indicated as improvement, and the proportion of subjects meeting this improvement criterion will also be compared among three groups by Chi-square statistics | 2010/12 | No |
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