Not Yet RecruitingNot Applicable

PQQ for Cognitive and Negative Symptoms

70 participantsStarted 2026-02-15

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: Eligible male and female patients aged 18 to 50 years, diagnosed with schizophrenia according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5), will be included in the study. Participants are required to meet the following criteria: a Positive and Negative Syndrome Scale (PANSS) total scores of ≥ 60 (indicating an active phase of the illness), a PANSS negative subscale scores of ≥ 20, and a duration of illness of at least 2 years (indicating chronic schizophrenia). Additionally, participants must have been on a stable dose of antipsychotic medication for a minimum of 6 weeks prior to enrollment, and the use of antioxidants or anti-inflammatory medications is prohibited within 2 weeks preceding enrollment. Exclusion criteria: Patients with comorbid psychiatric disorders as defined by the DSM-5, such as substance abuse or dependence (excluding nicotine), or intellectual disability (IQ \< 70); those with significant depressive symptoms, defined as a score ≥14 on the 17-item Hamilton Depression Rating Scale (HAMD-17) or ≥ 4 on the depression item of PANSS; individuals with severe medical or neurological conditions, or those unable to communicate effectively; patients with a known allergy to PQQ disodium salt, or who are pregnant, breastfeeding, or have severe hepatic or renal impairment; women of childbearing potential who are not using reliable contraception; patients who have recei…

What they're measuring

cognitive symptoms

Timeframe: From enrollment to the end of 12 weeks

negative symptoms

Timeframe: From enrollment to the end of 12 weeks

Trial details

NCT IDNCT07393464

SponsorTianjin Anding Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-15

Contact for this trial

Daxiang Medical Ethics Committee of Tianjin Anding Hospital

0086-22-88188631 tjadllwyh@126.com