Alpha-lipoic Acid Adjunctive Therapy in Schizophrenia
Status:
Enrolling by invitation
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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 social cognition/processing deficits of schizophrenia, which are
closely linked to real-world dysfunction and lack of socio-occupational integration. There is
compelling evidence for impaired antioxidant defense system and inflammatory abnormalities in
schizophrenia. A new therapeutic approach to the disease might well be to hinder oxidative
damage, inflammation and its clinical sequelae. Alpha-lipoic acid (ALA) is a naturally
occurring compound, synthesized in the mitochondria, that is currently approved to treat
diabetic neuropathic pain. Drug repurposing is a fast, and cost-effective method that can
overcome drug discovery challenges of targeting neuropsychiatric disorders. In a pilot
investigation, adjunctive treatment with ALA led to robust improvement in negative and
cognitive symptoms of ten patients with schizophrenia. This project aims to investigate the
efficacy of ALA as a disease-modifying drug for the treatment of schizophrenia, by improving
sociability and cognition, as well as to correlate patients' response with biomarkers that
will shed light on the pathophysiology of this complex disease. It comprises 1) a
prospective, randomized, double-blind, placebo-controlled trial to evaluate efficacy of ALA
to treat cognitive and negative symptoms of patients with schizophrenia and 2) an
investigation of changes in biomarkers of oxidative stress in response to adjunctive
treatment with ALA. The proposed study could establish a new adjunctive treatment for
schizophrenia, recognize a novel pharmacological approach and help unveil the biological
basis of the disease.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico