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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Wechsler Memory Scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hu ShaoHua
Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Zhejiang University