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

NCT01078870 | Unknown Phase 4

• 1 other identifier: 200907058M
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Negative symptom

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

A

EXPERIMENTAL

Drug: Lexapro

B

EXPERIMENTAL

Drug: Cymbalta

C

EXPERIMENTAL

Drug: Placebo

Interventions

Lexapro DRUG

10mg/cap 1\~2# QD

A

Cymbalta DRUG

30mg/cap 30\~60mg/QD

B

Placebo DRUG

1\~2#/cap QD

C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18-65
• meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) schizophrenia
• the genotype of NRG1-P3 is the homozygous risk genotype (TT)
• 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)
• having moderate to marked negative symptoms (scores between 4 to 6 in the items of N2, emotional withdrawal, and N4, passivity/apathetic social withdrawal)

You may not qualify if:

• 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
• the genotype of NRG1-P3 is TC or CC
• having any major systemic illness
• receiving first-generation antipsychotics or already on antidepressants or mood-stabilizing agents adjuvant
• substance abuse in the past 6 months
• pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Escitalopram; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring

Study Officials

• Liu Chih-Min, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2010
• First Posted: March 2, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 10, 2010

Record last verified: 2010-02

Locations

TW (1)