PQQ for Cognitive and Negative Symptoms

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorTianjin Anding Hospital

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: PQQ groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

cognitive symptoms

the changes in scores of MCCB between the baseline and the first post-treatment measurement.

Time frame
From enrollment to the end of 12 weeks
2

negative symptoms

the changes in scores of PANSS negative subscale between the baseline and the first post-treatment measurement.

Time frame
From enrollment to the end of 12 weeks

Secondary outcomes

1

congtive/negative symptoms

the scores of MCCB/PANSS negative subscale at the eight-week follow-up after withdrawal of PQQ treatment

Time frame
From enrollment to the end of 20 weeks
2

Malondialdehyde, Mitochondrial DNA, and Glutathione Peroxidase

The levels of biomarkers representing oxidative stress and inflammatory activity are assessed in venous blood.

Time frame
From enrollment to the end of 12 weeks and 20 weeks
3

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.

Time frame
From enrollment to the end of 12 weeks and 20 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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