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| Sponsor: | University of Alberta |
|---|---|
| Collaborator: |
Capital Health, Canada |
| Information provided by (Responsible Party): | Serdar Dursun, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00718510 |
Purpose
STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU) in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and depressive symptoms) and effectiveness of antipsychotic treatment
STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective disorder
Total expected number of patients: 14
INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total daily dose of 6 grams/day)
DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of second treatment phase (cross-over design)
EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects
ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4, cross-over phase: treatment phase-2; weeks 5,6,7
STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the between-subject factor and pre- and post-treatment scores as within- subjects factors.
DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full completion 18 months.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: L-Arginine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Cross-over, Placebo Controlled, Adjunctive-treatment of L-arginine Added to Treatment-as-usual (TAU) in Schizophrenia |
| Estimated Enrollment: | 14 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | October 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate contraception is defined as use of contraceptive double barrier system (i.e. condom and spermicide) or contraceptive implant, oral contraceptive or injected depot contraceptive plus other form of contraceptive, i.e. condom. Females will be considered incapable of child bearing if they are one year postmenopausal or irreversibly surgically sterilised.
Exclusion Criteria:
Relevant medical illness [serious renal, diabetes, hepatic, cardiac, low- or high-blood-pressure or other illnesses] in the opinion of the investigators. In particular, history of past or recent cardiac illness, MI and abnormal ECG and current treatments for cardiac illness. The results of the Laboratory Investigations (LFT, TFT, RFT, WBC, ECG, platelets, blood chemistry, lipids, weight/BMI) will be taken into account in determining the exclusion criteria.
Contacts and Locations| Canada, Alberta | |
| Alberta Hospital Edmonton | |
| Edmonton, Alberta, Canada, T5J 2J7 | |
| Principal Investigator: | Serdar Dursun, M.D., Ph.D. | University of Alberta |
| Principal Investigator: | Glen Baker, Ph.D., D.Sc. | University of Alberta |
| Principal Investigator: | John C. Lind, Ph.D. | Alberta Hospital Edmonton |
| Principal Investigator: | Phil Tibbo, F.R.C.P.C. | University of Alberta |
| Principal Investigator: | Mee-Sook Song, Ph.D. | University of Alberta |
| Principal Investigator: | Pierre Flor-Henry, F.R.C.P.C. | Alberta Hospital Edmonton |
| Principal Investigator: | Diane Cox, Ph.D. | University of Alberta |
More Information
| Responsible Party: | Serdar Dursun, Principal Investigator, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00718510 History of Changes |
| Other Study ID Numbers: | CPAT7176 |
| Study First Received: | July 16, 2008 |
| Last Updated: | January 25, 2012 |
| Health Authority: | Canada: Health Canada |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |