About this trial
Schizophrenia is a complex mental disorder characterized by a range of symptoms, including negative symptoms and cognitive impairments. Recent research has indicated the potential benefits of targeting mitochondrial dysfunction, oxidative stress, and inflammatory responses in alleviating symptoms of schizophrenia. However, the results remain inconsistent across various studies. This study aims to evaluate the efficacy of Pyrroloquinoline quinone (PQQ) in reducing negative symptoms and improving cognitive function in patients with chronic schizophrenia. The investigation will focus on changes in severity scores from baseline to endpoint, as well as during an eight-week follow-up period. A double-blind, randomized controlled trial will be conducted involving participants diagnosed with chronic schizophrenia. Participants will be randomly assigned to receive either PQQ or a matched placebo. Data will be collected through questionnaires and neuroimaging techniques, including resting-state scans and multimodal tasks to assess functional connectivity and activation in target brain regions. Statistical analyses will include descriptive statistics, voxel-by-voxel multiple regression, and linear mixed models to account for repeated measurements. Additionally, potential moderating effects of demographic factors such as age and gender will be examined using ANCOVAs. The study will also monitor adverse events and ensure participant safety through a rigorous reporting and unblinding procedure. It is hope to provide insights into the therapeutic potential of PQQ in managing schizophrenia symptoms, contributing to the development of more effective treatment strategies for this challenging condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Pyrroloquinoline quinone (PQQ)
Dietary supplementPatients with chronic schizophrenia in experimental group will take 20 mg of PQQ orally every day for a total of 12 weeks.
placebo (dietary fiber)
Dietary supplementPatients with chronic schizophrenia in control group will a capsule of placebo orally every day for a total of 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
cognitive symptoms
the changes in scores of MCCB between the baseline and the first post-treatment measurement.
negative symptoms
the changes in scores of PANSS negative subscale between the baseline and the first post-treatment measurement.
Secondary outcomes
congtive/negative symptoms
the scores of MCCB/PANSS negative subscale at the eight-week follow-up after withdrawal of PQQ treatment
Malondialdehyde, Mitochondrial DNA, and Glutathione Peroxidase
The levels of biomarkers representing oxidative stress and inflammatory activity are assessed in venous blood.
Connectivity strength of target neural circuits
The functional state of target brain regions and the connectivity strength of key neural circuits, including the prefrontal-parietal cognitive control network, the hippocampal-prefrontal memory circuit, and the thalamo-cortical information gating system.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: