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Development and application of precision treatment protocols for common mental disorders

Development and application of precision treatment protocols for common mental disorders

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086334
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, bipolar disorder and schizophrenia

Interventions

Guided:In the Guided group, clinicians selected drugs or maintained current treatment according to patients' symptoms, patients underwent pharmacogenomic testing, and got the test report within 3-5 wo
MDD: antidepressant monotherapy
BPD: mood stabilizer treatment, lithium/single-agent start valproic acid salt, and regular monitoring of blood concentration of lithium
If 2 to 4 weeks unable to control symptoms, considering the lithium/valproic acid salt, on the basis of a combination of a second mood stabilizer or psychiatric drugs). After 10 weeks of clinical obse
Unguided:Unguided group in the group by clinical doctors choose according to symptoms after drugs or maintain the current treatment, patients do drug genome testing, after 12 weeks of clinical observa

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Schizophrenia: 1) Han nationality, aged 18-65 years; 2) using the Mini-International Neuropsychiatric Interview (MINI) instrument and meeting the DSM-5 diagnostic criteria for schizophrenia; 3) the baseline when the Positive and Negative symptoms Scale score (Positive and Negative Syndrome Scale, PANSS) 60 or higher; 4) Junior high school or above education, no language communication disorder, can cooperate with evaluation and treatment, and patients or their guardians sign informed consent. Depressive disorder: 1) Han nationality, aged 18-65 years; 2) using the MINI tool, in line with DSM - depression diagnostic criteria for 5; 3) 17-item Hamilton Depression Scale (HAMD-17) = 17 at baseline; 4) Junior high school or above education, no language communication disorder, can cooperate with evaluation and treatment, and patients or their guardians sign informed consent. Bipolar disorder: 1) aged 18 to 65 years of age, gender not limited, the han nationality; 2) meet the diagnostic criteria of manic/hypomanic episode in DSM-5 using the MINI instrument; 3) Young Manic Rating Scale (YMRS) = 20 at baseline; 4) junior high school education or above, and there is no language barrier, can cooperate with the assessment and treatment, patients or patients with guardian sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) previous or current DSM-5 diagnoses: organic mental disorder, schizoaffective disorder, mental retardation, dementia, other cognitive disorders, alcohol and drug dependence, Axis II disorders; 2) severe suicidal tendency (moderate risk or above assessed by the Chinese version of MINI suicide module), with risk of wounding others; 3) with severe or unstable body disease; 4) narrow Angle glaucoma; 5) has a history of seizures; 6) known pregnant and/or lactation, or planning a pregnancy, 7) at the same time to participate in a clinical trial, wouldn't or couldn't complete the test of all procedures; 8) researchers think not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome (PANSS);Hamilton Depression Scale (HAMD);Young Manic Rating Scale (YMRS);

Secondary

MeasureTime frame
Clinical Global Impression (CGI);Morisky medication adherence scale (MMAS-8);Treatment Emergent Symptom Scale (TESS);Personal and Social Performance Scale (PSP);

Countries

China

Contacts

Public ContactWeihua Yue

Peking University Sixth Hospital

dryue@bjmu.edu.cn+86 188 1089 8027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026