Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders

NCT04218981 | Completed

• 1 other identifier: 81771447
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment. And explore whether there are shared imaging biomarkers between these three common mental disorders.

Conditions

Common Mental Disorder

Keywords

schizophrenia; bipolar disorder; neuroimaging; major depressive disorder

Outcome Measures

Primary Outcomes (5)

• Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants

  A 3.0 T Siemens scanner (Germany) was applied to obtain the MRI images in the Second Xiangya Hospital of Central South University.The MRI data will be obtained before and after treatment at different follow up point.All participants were told to lie on the scanner with their eyes closed. They wore soundproof headphones and asked to remain still. The parameters were as follows: repetition time of 2710 ms, echo time of 3.78 ms, flip angle of 7°, inversion time of 1000 ms, slice thickness of 1 mm, field of view of 256 mm × 256 mm, matrix of 256 × 256, no gap, and 188 slices.

  8 week

• Positive and Negative Syndrome Scale (PANSS)

  The PANSS total scores ,subscale scores were used to evaluate the severity of psychotic symptoms at baseline and eight weeks for schizophrenia.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.

  8 week

• Hamilton Depression Scale-17 (HAMD-17)

  HAMD-17 total scores were used to evaluate the severity of depressive symptoms at baseline and eight weeks for major depressive disorder. The total score of the HAMD-17 was more than 17.The higher scores mean a worse outcome.

  8 week

• Young Mania Rating Scale (YMRS)

  YMRS total scores were used to evaluate the severity of manic symptoms for bipolar disorder before and after treatment at different follow up point.The higher scores mean a worse outcome.

  8 week

• Brief Cognitive Assessment Tool for schizophrenia(B-CATS)

  The investigators will use the B-CATS scale to assess cognitive function before and after treatment at different follow up point.The higher scores mean a better outcome.

  8 week

Secondary Outcomes (1)

• Social Disability Screening Schedule(SDSS)

  8 week

Study Arms (4)

Schizophrenia group

EXPERIMENTAL

1. Schizophrenia was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks 3. Choose one of the antipsychotics drugs treatment( olanzapine, risperidone, aminosulpiride) according to the patient's condition

Drug: Antipsychotic drugs

Bipolar disorder group

EXPERIMENTAL

1. Bipolar disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks 3. Choose one of the mood stabilizer drugs treatment( lithium, valproate) according to the patient's condition

Drug: Mood stabilizer

Major depressive disorder group

EXPERIMENTAL

1. Major depressive disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). 2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks 3. Choose paroxetine treatment

Drug: Paroxetine

Healthy controls

NO INTERVENTION

MRI scan at baseline and no drugs treatment

Interventions

Antipsychotic drugs DRUG

Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group

Also known as: MRI scan

Schizophrenia group

Mood stabilizer DRUG

Choose lithium or valproate for bipolar disorder group

Also known as: MRI scan

Bipolar disorder group

Paroxetine DRUG

Patients with major depressive disorder are treated with paroxetine

Also known as: MRI scan

Major depressive disorder group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic criteria for schizophrenia,bipolar disorder, major depressive disorder according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
• Never received any treatment before.
• For healthy controls: their first-degree relative had no history of psychiatric disorders.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major

Interventions

Antipsychotic Agents; Magnetic Resonance Spectroscopy; Paroxetine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wenbin Guo

  The Second Xiangya Hospital, Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 6, 2020
• Study Start: January 15, 2020
• Primary Completion: June 25, 2023
• Study Completion: December 31, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)