Health Condition 1: null- Schizophrenia Health Condition 2: F20- Schizophrenia
Conditions
Interventions
Intervention1: Experimental: L-Dopa (Sinemet)
: Augmentation of current antipsychotic treatment with
oral L-Dopa (levodopa/carbidopa) up to 900mg daily
for 8 weeks
Control Intervention1: Not applicab
Sponsors
Dr Naren P Rao
Eligibility
Inclusion criteria
Inclusion criteria: (i) SCID-confirmed (Structured Clinical Interview for DSM-IV Axis I Disorders) diagnosis of schizophrenia (ii) ages 18-55 (iii) treatment with antipsychotic monotherapy; antipsychotic dose within, but not below or exceeding, current recommended guidelines
Exclusion criteria
Exclusion criteria: (i) history of substance abuse or dependence within 3 months (ii)positive urine drug screen; (iii) history or evidence of any disorder that might adversely influence cognitive measures (e.g. mental retardation); (iv) presence of serious neurological or general medical condition (e.g., Parkinsonâ??s disease, cardiac arrhythmia, epilepsy); (v) clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease, narrow-angle glaucoma, malignant melanoma; (vi) pregnancy/nursing (vii) nonselective monoamine oxidase (MAO) inhibitors within 2 weeks or use of a sympathomimetic amine; (viii) evidence of acute psychotic exacerbation in the last month; (x) acute suicidal risk; (xi) change in dose of current antipsychotic or concomitant psychotropic medications in the 8 weeks prior to study entry; (xii)presence of depressive symptoms, as defined by score >2 on 50% of items (â??moderateâ??), using the Calgary Depression Scale (xiii) parkinsonian symptoms, as defined by a score >8 on the Simpson-Angus Scale for Extrapyramidal Symptoms.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| AIMS - Abnormal Involuntary Movement ScaleTimepoint: 8weeks;BARS - Barnes Akathisia Rating ScalesTimepoint: 8weeks;BIS-11 - Barrett Impulsivity ScaleTimepoint: 8weeks;LUNSERS - Liverpool University Neuroleptic Side-Effect Rating ScaleTimepoint: 8weeks;MATRICS-Consensus Cognitive BatteryTimepoint: 8weeks;NIMH-MATRICS Brief Negative Symptoms ScaleTimepoint: 8weeks;SAS - Simpson Angus Scale for Extrapyramidal SymptomsTimepoint: 8weeks;UKU - Udvalg for Kliniske UndersogelsesTimepoint: 8weeks;BPRS-Brief Psychotic Rating ScaleTimepoint: 8weeks;CDS - Calgary Depression ScaleTimepoint: 8weeks;CGI-S - Clinical Global Impression - Severity ScaleTimepoint: 8weeks;DAI - Drug Attitude InventoryTimepoint: 8weeks;fMRI - Functional Magnetic Resonance Imaging Changes in Regional Brain Activity Timepoint: 8weeks;QLS - Quality of Life ScaleTimepoint: 8weeks;SAPS-Schedule for the Assessment of Positive SymptomsTimepoint: 8weeks;SWN - Subjective Well-Being on Neuroleptics ScaleTimepoint: 8weeks;Y-BOCS - Yale-Brown Obsessive Compulsive ScaleTimepoint: 8weeks | — |
Primary
| Measure | Time frame |
|---|---|
| SANS - Schedule for the Assessment of Negative SymptomsTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Naren P Rao
National Institute of Mental health and neurosciences (NIMHANS)
Outcome results
None listed