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Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia

NCT03548155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-07-25

No results posted yet for this study

Summary

The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.

Conditions

Interventions

DRUG

Berberine

Berberine 300mg（three times a day） plus any atypical antipsychotic drug

DRUG

atypical antipsychotic

Any atypical antipsychotic drug as the basic treatment

DRUG

placebo

The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles

Sponsors & Collaborators

  • Tianjin Anding Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
62 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-24
Primary Completion
2015-12-14
Completion
2017-05-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548155 on ClinicalTrials.gov