Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

NCT04207385 | Unknown Phase 4 DMC

• 1 other identifier: KY20192104-X-1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of PGx-guided medication in patients with depression treated with Venlafaxine and the efficacy of the combination of PGx and TDM in patients with depression treated with Venlafaxine. Half of participants will receive PGx-guided treatment, while the other half will receive routine treatment. After the 8th week, the PGx-guided treatment group would be randomly divided into two groups. Of which, half of participants will receive the combination of PGx and TDM, and the other half will receive PGx -guided medication only.

Conditions

Depression

Keywords

pharmacogenomics; PGx; therapeutic drug monitoring; TDM; Venlafaxine; depression

Outcome Measures

Primary Outcomes (1)

• Score reduction rate of Hamilton Depression Rating Scale

  Reduction Rate=\[(total score before treatment-total score after treatment)/total score before treatment\] \*100% * Healed: reduction rate ≥ 75%; * Significant Effective: reduction rate≥50％and \<75％; ③Effective: reduction rate≥25％ and \<50％; ④Invalid: Reduction rate \< 25%

  3 days

Study Arms (4)

A group: Routine treatment group

ACTIVE COMPARATOR

Routine dosage of venlafaxine during the first 4 weeks.

Drug: Venlafaxine

B group: PGx-guided group

EXPERIMENTAL

The PGx test results guide the dosage of venlafaxine during the first 4 weeks.

Diagnostic Test: pharmacogenomics; Drug: Venlafaxine

C group: Routine PGx-guided group

ACTIVE COMPARATOR

The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.

Diagnostic Test: pharmacogenomics; Drug: Venlafaxine

D group: The combination of PGx and TDM group

ACTIVE COMPARATOR

The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.

Diagnostic Test: pharmacogenomics; Diagnostic Test: pharmacogenomics & therapeutic drug monitoring; Drug: Venlafaxine

Interventions

pharmacogenomics DIAGNOSTIC_TEST

pharmacogenomics

B group: PGx-guided group; C group: Routine PGx-guided group; D group: The combination of PGx and TDM group

pharmacogenomics & therapeutic drug monitoring DIAGNOSTIC_TEST

pharmacogenomics \& therapeutic drug monitoring

D group: The combination of PGx and TDM group

Venlafaxine DRUG

Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning

A group: Routine treatment group; B group: PGx-guided group; C group: Routine PGx-guided group; D group: The combination of PGx and TDM group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with endogenous depression, with any of the following 4 symptoms: ① Interest Loss; ② Hypothymia; ③ Early awakening; ④ Serious in the morning and relieved at night; ⑤ Hysteresis or agitation of movement of Spirit; ⑥ Appetite loss; ⑦ Weight loss; ⑧ Loss of libido;
• Scores of 17 items in Hamilton Depression Scale (HAM-D17): over 17 points;
• First-episode patients or relapsed patients without taking any antidepressant drugs in the recent 3 months;
• No significant abnormalities are shown in physical examination (temperature, pulse, blood pressure, head and neck, chest and abdomen).
• No obvious abnormalities in laboratory examination (Thyroid Function).
• Informed patient consent.

You may not qualify if:

• Those diagnosed with mental disorders other than major depressive disorders (with the exception of combination of anxiety disorders); non-endogenous depressive disorders;
• Patients with stroke, brain tumor and other brain organic diseases;
• Patients receiving combined drugs (but there is no need to exclude patients receving drugs against sleep disorders, such as Eszopiclone, alprazolam or estazolam);
• History of drug allergy;
• Pregnant and lying-in women;
• Patients with serious suicidal tendencies.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Pharmacogenomic Testing; Drug Monitoring; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Monitoring, Physiologic; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Huaning Wang

  Deputy Chief Physician

  STUDY CHAIR

• Ping Zhou

  Attending Physician

  PRINCIPAL INVESTIGATOR

• Yihuan Chen

  Attending Physician

  PRINCIPAL INVESTIGATOR

• Huizhen Lu

  Resident Physician

  PRINCIPAL INVESTIGATOR

• Qinghong Yan

  Nurse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaning Wang

CONTACT

+86 13609161341; xskzhu@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: December 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: November 20, 2021
• Last Updated: December 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)