N/A
N=15
L-arginine in Treatment as Usual in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00718510 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks — 71.6; 72.2; 68.0; 70.2 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- L-Arginine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks |
71.6; 72.2; 68.0; 70.2; 14.6; 14.3 | <0.05 sig |
| SECONDARY Change From Baseline in Mean Clinical Global Impression (CGI) Scale at 3 Weeks |
4.0; 4.0; 3.6; 3.7 | 0.46 |
| SECONDARY Change From Baseline in Mean Calgary Depression Scale for Schizophrenia (CDSS) at 3 Weeks |
4.5; 4.5; 3.4; 3.8 | 0.55 |
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.
Eligibility Criteria
Inclusion Criteria
- Aged 18-65 years
- Diagnoses of schizophrenia or schizoaffective disorder using the Diagnostic and Statistical Manual-IV (DSM-IV) criteria
- Competent and willing to give informed consent
- Able to take oral medication and likely to complete the required evaluations.
- Medication remained stable 4 weeks prior to baseline.
- Female participants of child bearing capability must be willing to use adequate contraceptives (4.6.1a) for the duration of the study, and, willing to have a pregnancy test pretreatment and during the study.
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.
- Relevant medical illness will be determined in the first instance by asking the patients mental health care team if the patient has any medical condition/problems. After consent has been obtained, the research nurse/research doctor will then have access to the patient's notes and if necessary communicate with his/her GP and will assess patient eligibility to take part in the clinical trial by scrutinising the patient's past medical history, most recent blood results, electrocardiograms, as well as any physical tests that have been performed on the patient. If there are any deviations from the 'norm' the investigators will assess the eligibility of the individual patient.
- Patients receiving active treatments for Herpes virus as L-arginine may counteract the benefits of lysine to treat herpes virus
- Patients who are currently receiving NSAIDs or other drugs that can cause significant stomach an gastrointestinal side-effects
- Drugs that alter potassium levels in the body, such as ACE inhibitors and potassium sparing diuretics
- Patients who are pregnant or plan to become pregnant while using this amino acid
- Patients who are breastfeeding
- Prior history of intolerance to L-arginine
- Any significant change of psychotropic medications done within the previous 4 weeks
- Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-IV criteria
Data sourced from ClinicalTrials.gov (NCT00718510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.