| CTRI Number |
CTRI/2018/08/015367 [Registered on: 16/08/2018] Trial Registered Prospectively |
| Last Modified On: |
07/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of adding a medicine (called levodopa) to existing treatment in patients with schizophrenia |
|
Scientific Title of Study
|
Augmentation of antipsychotics with levodopa - fMRI study to examine neurobiological effects of L-dopa in Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 156/2011 |
Protocol Number |
| NCT01636037 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naren P Rao |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental health and neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental health and neurosciences (NIMHANS) Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995879 |
| Fax |
|
| Email |
narenrao@nimhans.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naren P Rao |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental health and neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental health and neurosciences (NIMHANS) Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995879 |
| Fax |
|
| Email |
narenrao@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naren P Rao |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental health and neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental health and neurosciences (NIMHANS) Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995879 |
| Fax |
|
| Email |
narenrao@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| Brain And Behavior research foundation, New york, USA |
|
|
Primary Sponsor
|
| Name |
Dr Naren P Rao |
| Address |
Department of Psychiatry
National Institute of Mental Health and Neurosciences
Hosur road |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naren P Rao |
National Institute of Mental Health and Neurosciences |
Room no 1
Project wing,Below POGW
National Institute of Mental Health and Neurosciences
Hosur road
Bangalore
KARNATAKA |
080269925879
narenrao@nimhans.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neurosciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Schizophrenia , (1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental: L-Dopa (Sinemet)
|
Augmentation of current antipsychotic treatment with
oral L-Dopa (levodopa/carbidopa) up to 900mg daily
for 8 weeks
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
(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 |
|
| ExclusionCriteria |
| Details |
(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., Parkinson’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 (‘moderate’), using
the Calgary Depression Scale
(xiii) parkinsonian symptoms, as defined by a score >8 on the
Simpson-Angus Scale for Extrapyramidal Symptoms. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SANS - Schedule for the Assessment of Negative Symptoms |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MATRICS-Consensus Cognitive Battery |
8weeks |
| BPRS-Brief Psychotic Rating Scale |
8weeks |
| SAPS-Schedule for the Assessment of Positive Symptoms |
8weeks |
| NIMH-MATRICS Brief Negative Symptoms Scale |
8weeks |
| CGI-S - Clinical Global Impression - Severity Scale |
8weeks |
| QLS - Quality of Life Scale |
8weeks |
| CDS - Calgary Depression Scale |
8weeks |
| SAS - Simpson Angus Scale for Extrapyramidal Symptoms |
8weeks |
| BARS - Barnes Akathisia Rating Scales |
8weeks |
| AIMS - Abnormal Involuntary Movement Scale |
8weeks |
| UKU - Udvalg for Kliniske Undersogelses |
8weeks |
| LUNSERS - Liverpool University Neuroleptic Side-Effect Rating Scale |
8weeks |
| BIS-11 - Barrett Impulsivity Scale |
8weeks |
| Y-BOCS - Yale-Brown Obsessive Compulsive Scale |
8weeks |
| DAI - Drug Attitude Inventory |
8weeks |
fMRI - Functional Magnetic Resonance Imaging
Changes in Regional Brain Activity
|
8weeks |
| SWN - Subjective Well-Being on Neuroleptics Scale |
8weeks |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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. a. L-dopa will prove effective in improving deficit (also called ’primary negative’ e.g. amotivation) and cognitive symptoms in schizophrenia. b. It will be well tolerated and not increase risk of psychotic symptoms when administered in conjunction with their regular antipsychotic medications. |