L-arginine in Treatment as Usual in Schizophrenia

Summary

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.

Conditions

• Schizophrenia

Interventions

DRUG

L-Arginine

3 grams, twice daily, oral administration

Sponsors & Collaborators

• Alberta Health services

  collaborator OTHER

• University of Alberta

  lead OTHER

Principal Investigators

• Serdar Dursun, M.D., Ph.D. · University of Alberta

• Glen Baker, Ph.D., D.Sc. · University of Alberta

• John C. Lind, Ph.D. · Alberta Hospital Edmonton

• Phil Tibbo, F.R.C.P.C. · University of Alberta

• Mee-Sook Song, Ph.D. · University of Alberta

• Pierre Flor-Henry, F.R.C.P.C. · Alberta Hospital Edmonton

• Diane Cox, Ph.D. · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2011-07-31

Completion

2012-10-31

Countries

• Canada

Study Locations