L-arginine in Treatment as Usual in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00718510|
Recruitment Status : Completed
First Posted : July 18, 2008
Results First Posted : September 5, 2017
Last Update Posted : September 5, 2017
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 or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: L-Arginine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Double-blind, Cross-over, Placebo Controlled, Adjunctive-treatment of L-arginine Added to Treatment-as-usual (TAU) in Schizophrenia|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||October 2012|
Active Comparator: L-arginine first/placebo second
Patients with diagnosis of schizophrenia will be randomised to receive L-arginine first/placebo second 3 grams bid (cross-over design) in addition to treatment as usual. The active treatment period will be 3 weeks, with a wash-out period of 5 days and re-commencing on the alternative arm of the randomization
3 grams, twice daily, oral administration
Other Name: Placebo
Placebo Comparator: Placebo first/L-arginine second
Patients with diagnosis of schizophrenia will be randomised to receive placebo first/L-arginine second 3 grams bid (cross-over design) in addition to treatment as usual. The active treatment period will be 3 weeks, with a wash-out period of 5 days and re-commencing on the alternative arm of the randomization
3 grams, twice daily, oral administration
Other Name: Placebo
- Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks [ Time Frame: Baseline and 3 Weeks ]The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score and PANSS positive, negative and general psychopathology subscale scores. The PANSS is a 30-item scale used to evaluate the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranges from 30 to 210 with a higher score indicating a greater severity of symptoms. The PANSS positive symptom subscale score (7 items) ranges from 7=absent to 49=extreme; the PANSS negative subscale score (7 items) ranges from 7=absent to 49=extreme; and the PANSS general psychopathology subscare score (16 items) ranges from 16=absent to 112=extreme.
- Change From Baseline in Mean Clinical Global Impression (CGI) Scale at 3 Weeks [ Time Frame: Baseline and 3 Weeks ]The Secondary Outcome Measure was the Clinical Global Impression (CGI) scale. The CGI is a 3-item scale that rates treatment response and monitors the clinical course of all psychiatric illnesses including schizophrenia. Within the CGI, the Severity of Illness was rated on a 7-point scale, 0=not assessed to 7=among the most severely ill patients. For Global Improvement, the total improvement following treatment as compared to at baseline of the trial was rated on a 7-point scale, 0=not assessed to 7=very much worse.
- Change From Baseline in Mean Calgary Depression Scale for Schizophrenia (CDSS) at 3 Weeks [ Time Frame: Baseline and 3 Weeks ]The Secondary Outcome Measure was the Calgary Depression Scale for Schizophenia (CDSS). The CDSS is a 9-item scale that is used to rate the depressive symptoms in patients with schizophrenia. For each CDSS item, symptom severity was rated on a 3-point scale, from 0=absent to 3=severe. The CDSS total score ranges from 0 to 27 with a higher score indicating a greater severity of symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718510
|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|