Status:
COMPLETED
Alpha-lipoic Acid Adjunctive Therapy in Schizophrenia
Lead Sponsor:
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Schizophrenia
Oxidative Stress
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Schizophrenia is a devastating mental disorder with a prevalence of approximately 1% worldwide. While effective in reducing positive symptoms, current treatments have limited effects on cognitive and ...
Detailed Description
The underlying pathogenesis of schizophrenia remains unknown, but aberrant reduction-oxidation has gained increasing support as an hypothesis to help explain the pathophysiology of the disease. Alpha-...
Eligibility Criteria
Inclusion
- Capacity to provide informed consent;
- Schizophrenia diagnosis (made by research psychiatrists using the Structured Clinical Interview, SCID-5, for Diagnostic and Statistical Manual of Mental Disorders);
- Negative and/or cognitive symptoms despite adequate antipsychotic treatment;
- Ages 18-60 years
Exclusion
- 6-month history of any drug or alcohol abuse or dependence;
- Changes in psychotropic medications within the last 4 weeks;
- Actual valproate use (potential interaction with ALA);
- General medical illness including autoimmune disorders, known chronic infections such as HIV or hepatitis C, and liver or renal failure that could adversely impact on patient outcome;
- Women who are planning to become pregnant, are pregnant, or are breastfeeding.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03788759
Start Date
September 1 2019
End Date
December 1 2021
Last Update
August 29 2022
Active Locations (1)
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1
Núcleo de Pesquisa e Desenvolvimento de Medicamentos - UFC
Fortaleza, Ceará, Brazil, 60430-275