Antipsychotic Augmentation With L-Dopa

NCT01636037 | Completed Phase 2 DMC

• 1 other identifier: 156/2011
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

1. 1.L-dopa will prove effective in improving deficit (also called 'primary negative' e.g. amotivation) and cognitive symptoms in schizophrenia.
2. 2.It will be well tolerated and not increase risk of psychotic symptoms when administered in conjunction with their regular antipsychotic medications.

Conditions

Schizophrenia

Keywords

schizophrenia; negative symptoms; deficit syndrome; SANS; Sinemet; L-dopa; levodopa; carbidopa; augmentation; antipsychotics

Outcome Measures

Primary Outcomes (1)

• SANS - Schedule for the Assessment of Negative Symptoms

  8 weeks

Secondary Outcomes (17)

• MATRICS-Consensus Cognitive Battery

  8 weeks

• BPRS - Brief Psychotic Rating Scale

  8 weeks

• SAPS - Schedule for the Assessment of Positive Symptoms

  8 weeks

• NIMH-MATRICS Brief Negative Symptoms Scale

  8 weeks

• CGI-S - Clinical Global Impression - Severity Scale

  8 weeks

Study Arms (1)

L-Dopa (Sinemet)

EXPERIMENTAL

Augmentation of current antipsychotic treatment with oral L-Dopa (levodopa/carbidopa) up to 900mg daily for 8 weeks

Drug: levodopa/carbidopa (generic version of Sinemet)

Interventions

levodopa/carbidopa (generic version of Sinemet) DRUG

Oral levodopa 900mg daily as tolerated.

Also known as: Levodopa/carbidopa, Sinemet

L-Dopa (Sinemet)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SCID-confirmed (Structured Clinical Interview for DSM-IV Axis I Disorders) diagnosis of schizophrenia
• ages 18-55

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre.

MeSH Terms

Conditions

Schizophrenia

Interventions

Levodopa; Carbidopa; carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Study Officials

• Gary Remington, MD PhD FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)