Depression
Conditions
Interventions
The study is a randomized, double-blind, placebo-controlled clinical trial. Neither the participants nor the researchers will know which group is receiving alpha-lipoic acid or the placebo, ensuring p
E02.319
Sponsors
Departamento de Fisiologia e Farmacologia da Universidade Federal do Ceará
Departamento de Fisiologia e Farmacologia da Universidade Federal do Ceará
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Male or female participants; aged between 18 and 50 years; diagnosed with moderate depression, assessed using the Hamilton scale; undergoing stable treatment with an antidepressant from the Selective Serotonin Reuptake Inhibitor class for at least four weeks before inclusion in this study; receiving care at the Psychiatry Outpatient Clinic of the Walter Cantídio University Hospital; willing to maintain this medication during the study; capable of understanding the nature and objectives of the study, including its risks and benefits, and willing to cooperate with the researcher and comply with the protocol requirements, as confirmed by signing the Informed Consent Form; patients who do not have clinical conditions that could interfere with the results, such as uncontrolled chronic diseases (diabetes, heart disease, liver disease, and kidney disease)
Exclusion criteria
Exclusion criteria: Participant with a history of severe psychiatric disorders (e.g., bipolar disorder, schizophrenia) or substance abuse; history of autoimmune or inflammatory diseases that may alter cytokine production, or any condition that affects the metabolism of alpha-lipoic acid; known history of hypersensitivity to alpha-lipoic acid or any component of the formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the reduction in the severity of mood symptoms and emotional dysregulation, measured by the Hamilton depression scale | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome of this study includes the improvement in the scores of neuropsychological tests that assess cognitive and executive function, the improvement in the parameters of analysis of oxidative stress, including the levels of reduced glutathione, thiobarbituric acid reactive substances and nitrite, the improvement in the levels of brain-derived neurotrophic factor, the improvement in the inflammatory parameters with the dosage of interleukin four and interleukin six, the improvement in the levels of total cholesterol and its fractions, the changes in the body weight of the patients and the reduction of body weight | — |
Countries
Brazil
Contacts
Public ContactSilvania Patrocínio
Universidade Federal do Ceará
Outcome results
None listed