NCT07393464

PQQ for Cognitive and Negative Symptoms

The Efficacy and Safety of Pyrroloquinoline Quinone add-on Treatment for Negative and Cognitive Symptoms in Chronic Schizophrenia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia
• Cognitive Symptoms
• Negative Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pyrroloquinoline quinone (PQQ)	Patients with chronic schizophrenia in experimental group will take 20 mg of PQQ orally every day for a total of 12 weeks.
DIETARY_SUPPLEMENT	placebo (dietary fiber)	Patients with chronic schizophrenia in control group will a capsule of placebo orally every day for a total of 12 weeks.

Timeline

• Start date: 2026-02-15
• Primary completion: 2028-02-15
• Completion: 2028-04-15
• First posted: 2026-02-06
• Last updated: 2026-02-10