PQQ for Cognitive and Negative Symptoms

Sponsor
Tianjin Anding Hospital
Study ID
NCT07393464
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Pyrroloquinoline quinone (PQQ) — DIETARY_SUPPLEMENT
    Patients 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_SUPPLEMENT
    Patients with chronic schizophrenia in control group will a capsule of placebo orally every day for a total of 12 weeks.

Study Details

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.

Key Dates

First listed
Feb 6, 2026
Start date
Feb 15, 2026
Status verified
Feb 2026
Primary completion
Feb 15, 2028
Completion
Apr 15, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PQQ group
  • Placebo Comparator: Control group

Primary Outcome Measure

cognitive symptoms [ Time Frame: From enrollment to the end of 12 weeks ]

Central Contacts

  • Daxiang Medical Ethics Committee of Tianjin Anding Hospital
    0086-22-88188631
    [email protected]

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