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Clinical Trials/NCT05596461
NCT05596461
Recruiting
N/A

Research on New Techniques for Diagnosis and Treatment of Neuropsychiatric Diseases - Research on New Techniques for Diagnosis and Treatment of Affective Disorders and Cognitive Impairment

First Affiliated Hospital of Zhejiang University1 site in 1 country90 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Affective Disorder
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
90
Locations
1
Primary Endpoint
Wechsler Memory Scale
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Hu ShaoHua

Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University

First Affiliated Hospital of Zhejiang University

Eligibility Criteria

Inclusion Criteria

  • Age 16-65 years old, regardless of gender;
  • Meet DSM-V diagnostic criteria for depression or bipolar disorder;
  • Duration of stable period ≥ 3 months;
  • Young Mania Rating Scale (YMRS) ≤ 6 points;
  • Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7;
  • The score of cognitive defects questionnaire (PDQ) ≥ 17;
  • Han nationality, right-handed;
  • More than 9 years of education.

Exclusion Criteria

  • History of severe somatic or brain organic diseases and craniocerebral trauma;
  • Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
  • Those who do not cooperate or cannot effectively complete the experiment;
  • Drug, alcohol or other psychoactive substance abusers;
  • Pregnant, lactating or planned pregnancy.

Outcomes

Primary Outcomes

Wechsler Memory Scale

Time Frame: 0-8 weeks

The Wechsler Memory Scale score was used to evaluate the degree of cognitive function, and the lower the score, the more severe the cognitive function impairment. The scoring threshold is 70 points. A lower score means more severe cognitive impairment.

Study Sites (1)

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