Schizophrenia Clinical Trial
Official title:
Augmentation of Antipsychotics With L-Dopa (Sinemet)
Verified date | March 2016 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Dopamine, a chemical in the brain, has been linked to schizophrenia for a number of years.
More recently, there is evidence that certain areas affected in schizophrenia (e.g.
motivation, cognition) may reflect too little dopamine, whereas symptoms like hallucinations
and delusions have been linked to too much dopamine.
This study is designed to evaluate the safety, tolerability, and efficacy of giving L-dopa
(Sinemet) to see if it will improve those symptoms related to too little dopamine. L-dopa
has been approved for other medical conditions (e.g. Parkinson's disease) and works to
increase levels of dopamine.
The investigators are linking this study with neuroimaging (fMRI) which will allows us to
link any changes the investigators might find in clinical symptoms with changes in the
brain. This information can prove useful in better understanding the mechanisms that account
for these symptoms, as well as possible new treatments.
At present , treatments for these other symptoms that seem important in functional measures
of outcome (i.e. deficit symptoms, including amotivation; cognitive symptoms) in
schizophrenia have not proven particularly effective. It is hoped that L-dopa may provide a
treatment that is more effective; going forward, this information would also be useful in
drug development and future lines of investigation.
1. L-dopa will prove effective in improving deficit (also called 'primary negative' e.g.
amotivation) and cognitive symptoms in schizophrenia.
2. It will be well tolerated and not increase risk of psychotic symptoms when administered
in conjunction with their regular antipsychotic medications.
Status | Completed |
Enrollment | 13 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - SCID-confirmed (Structured Clinical Interview for DSM-IV Axis I Disorders) diagnosis of schizophrenia - ages 18-55 Exclusion Criteria: - history of substance abuse or dependence within 3 months; (ii) positive urine drug screen - history or evidence of any disorder that might adversely influence cognitive measures (e.g. mental retardation) - presence of serious neurological or general medical condition (e.g., Parkinson's disease, cardiac arrhythmia, epilepsy) - clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease, narrow-angle glaucoma, malignant melanoma - pregnancy/nursing or women of child-bearing age not on regular contraceptive therapy (effects of L-dopa unknown) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SANS - Schedule for the Assessment of Negative Symptoms | 8 weeks | No | |
Secondary | MATRICS-Consensus Cognitive Battery | 8 weeks | No | |
Secondary | BPRS - Brief Psychotic Rating Scale | 8 weeks | No | |
Secondary | SAPS - Schedule for the Assessment of Positive Symptoms | 8 weeks | No | |
Secondary | NIMH-MATRICS Brief Negative Symptoms Scale | 8 weeks | No | |
Secondary | CGI-S - Clinical Global Impression - Severity Scale | 8 weeks | No | |
Secondary | QLS - Quality of Life Scale | 8 weeks | No | |
Secondary | CDS - Calgary Depression Scale | 8 weeks | No | |
Secondary | SAS - Simpson Angus Scale for Extrapyramidal Symptoms | 8 weeks | No | |
Secondary | BARS - Barnes Akathisia Rating Scales | 8 weeks | No | |
Secondary | AIMS - Abnormal Involuntary Movement Scale | 8 weeks | No | |
Secondary | UKU - Udvalg for Kliniske Undersogelses | Measures General Side Effects | 8 weeks | No |
Secondary | LUNSERS - Liverpool University Neuroleptic Side-Effect Rating Scale | 8 weeks | No | |
Secondary | BIS-11 - Barrett Impulsivity Scale | 8 weeks | No | |
Secondary | Y-BOCS - Yale-Brown Obsessive Compulsive Scale | 8 weeks | No | |
Secondary | DAI - Drug Attitude Inventory | 8 weeks | No | |
Secondary | fMRI - Functional Magnetic Resonance Imaging | Changes in Regional Brain Activity | 8 weeks | No |
Secondary | SWN - Subjective Well-Being on Neuroleptics Scale | 8 weeks | No |
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