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Effects of different CYP2D6 metabolizers on clinical response and adverse reaction of paroxetine in the treatment of depressive and anxiety disorder

Effects of different CYP2D6 metabolizers on clinical response and adverse reaction of paroxetine in the treatment of depressive and anxiety disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038462
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-09-20
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Depression, generalized anxiety disorder, panic disorder

Interventions

Depression:Paroxetine
Generalized Anxiety Disorder:Paroxetine
Panic Disorder:Paroxetine

Sponsors

Institute of Mental Health, the Sixth Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Study on the efficacy and adverse reactions of different CYP2D6 metabolites in the treatment of depression (1) The standard age of the patients was 18-65 years old; (2) Outpatients or inpatients; (3) Patients who met dsm-5 criteria for major depressive disorder; (4) Patients with HAMD-17 score >= 17; (5) Patients with manic symptom checklist-32 (hcl-32) = 14; (5) Patients with first onset (course of disease less than 3 months) or relapsed patients who have stopped antidepressant treatment for more than 3 months; (6) Patients who did not receive any systematic anti anxiety and depression treatment and did not use drugs that induce or inhibit metabolism of CYP2D6 within 2 weeks before enrollment; (7) Patients with junior high school education or above have no language communication barrier, can cooperate with assessment and treatment, and sign informed consent. 3. Study on the efficacy and adverse reactions of paroxetine in the treatment of panic disorder with different CYP2D6 metabolic types (1) Patients aged 18-65 years, of either gender, Han nationality; (2) Outpatients or inpatients; (3) Patients who met the dsm-5 criteria for panic disorder; (4) Patients with PDSS score >= 7; (5) Patients with first onset (course of disease less than 3 months) or relapsed patients who have stopped antidepressant treatment for more than 3 months; (6) Patients who did not receive any systematic anti anxiety and depression treatment and did not use drugs that induce or inhibit metabolism of CYP2D6 within 2 weeks before enrollment; (7) Patients with junior high school education or above have no language communication barrier, can cooperate with assessment and treatment, and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria of different CYP2D6 metabolites on the efficacy and adverse reactions of paroxetine in the treatment of depression: 1 (1) The patients who met the dsm-5 diagnosis before or at present: organic mental disorder, schizophrenia, schizophrenic affective disorder, bipolar disorder, mental retardation, dementia, other cognitive disorders, alcohol dependence and personality disorder, etc; (2) Patients with serious suicidal tendency are at risk of injury; (3) Patients with severe or unstable physical diseases; (4) Patients with narrow angle glaucoma had a history of epilepsy; (5) Known pregnancy and / or breastfeeding, or planned pregnancy; (6) Patients who participated in another clinical trial at the same time were unwilling or unable to complete the whole course of the trial; (7) Excluding physical diseases such as epilepsy, cardiovascular disease, pheochromocytoma, hyperthyroidism, or secondary depression and anxiety disorders such as spontaneous hypoglycemia. 2. Exclusion criteria for efficacy and adverse reactions of paroxetine in the treatment of generalized anxiety disorder with different CYP2D6 metabolic types (1) Patients who had been diagnosed with dsm-5 or below; (2) Patients with organic mental disorder, schizophrenia, schizophrenic affective disorder, bipolar disorder, mental retardation, dementia, other cognitive impairment, alcohol and drug dependence personality disorder; (3) Patients with serious suicidal tendency are at risk of injury; (4) Patients with severe or unstable physical diseases; (5) Patients with narrow angle glaucoma had a history of epilepsy; (6) Known pregnancy and / or breastfeeding, or planned pregnancy; (7) Patients who participated in another clinical trial at the same time were unwilling or unable to complete the whole course of the trial; (8) Depression and anxiety disorder secondary to somatic diseases such as epilepsy, cardiovascular disease, pheochromocytoma, hyperthyroidism or spontaneous hypoglycemia were excluded. 3. Exclusion criteria for efficacy and adverse reactions of paroxetine in the treatment of panic disorder with different CYP2D6 metabolites (1) The patients who met the dsm-5 diagnosis before or at present: organic mental disorder, schizophrenia, schizophrenic affective disorder, bipolar disorder, mental retardation, dementia, other cognitive disorders, alcohol dependence personality disorder, etc; (2) Patients with serious suicidal tendency are at risk of injury; (3) Patients with severe or unstable physical diseases; (4) Patients with narrow angle glaucoma had a history of epilepsy; (5) Known pregnancy and / or breastfeeding, or planned pregnancy; (6) Patients who participated in another clinical trial at the same time were unwilling or unable to complete the whole course of the trial; (7) Patients with physical diseases such as epilepsy, cardiovascular disease, pheochromocytoma, hyperthyroidism or spontaneous hypoglycemia were excluded. 4. Exit and termination criteria: Once the above exclusion criteria appear in the recruited patients, or the patients have intolerable adverse reactions, or the patients withdraw their informed consent to withdraw, the patients will immediately withdraw and terminate the study. Doctors should give termination evaluation and cooperate to develop necessary clinical alternative treatment.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale, HAMD;Hamilton Anxiety Scale, HAMA;Panic Disorder Severity Scale, PDSS;

Secondary

MeasureTime frame
Clinical global impression, CGI;Treatment Emergent Symptom Scale, TESS;

Countries

China

Contacts

Public ContactYue Weihua

Institute of Mental Health, the Sixth Hospital of Peking University

dryue@bjmu.edu.cn+86 10 82805307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026