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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Drug: Venlafaxine; Diagnostic test: pharmacogenomics; Diagnostic test: pharmacogenomics & therapeutic drug monitoring

Detailed Description

The current clinical medication is based on "Trial and Error", while the traditional medication is mainly based on experience. The study mainly optimizes the treatment path from two perspectives: to help clinicians select drugs accurately through the detection of PGx; to help clinicians monitor the whole process of drug use through TDM and adjust the dosage in time to achieve better treatment.

PGx tests take the information of metabolic, transporting and target genetic factors into account comprehensively. Furthermore, clinical effects depend on blood concentration rather than dose concentration. TDM aims to monitor blood concentration, which is related to drug efficacy and toxicity.

Venlafaxine is an antidepressant drugs of the 5-hydroxytryptamine selective seratonin re-uptake inhibitors (SSRIs), which has been approved by FDA for the treatment of depressive disorders, depressive disorders with anxiety symptoms, generalized anxiety disorders and social anxiety disorders since 1994.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Huaning Wang; Phone Number: +86 13609161341; Email: xskzhu@fmmu.edu.cn

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: A group: Routine treatment group; Routine dosage of venlafaxine during the first 4 weeks.	Drug: Venlafaxine; Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning
EXPERIMENTAL: B group: PGx-guided group; The PGx test results guide the dosage of venlafaxine during the first 4 weeks.	Drug: Venlafaxine; Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning; Diagnostic test: pharmacogenomics; pharmacogenomics
ACTIVE_COMPARATOR: C group: Routine PGx-guided group; The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.	Drug: Venlafaxine; Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning; Diagnostic test: pharmacogenomics; pharmacogenomics
ACTIVE_COMPARATOR: D group: The combination of PGx and TDM group; The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.	Drug: Venlafaxine; Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning; Diagnostic test: pharmacogenomics; pharmacogenomics; Diagnostic test: pharmacogenomics & therapeutic drug monitoring; pharmacogenomics & therapeutic drug monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Huaning Wang, Deputy chief physician; Principal Investigator: Ping Zhou, Attending Physician; Principal Investigator: Yihuan Chen, Attending Physician; Principal Investigator: Huizhen Lu, Resident Physician; Principal Investigator: Qinghong Yan, Nurse

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): November 20, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (ACTUAL): December 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: depression; Venlafaxine; pharmacogenomics; TDM; PGx; therapeutic drug monitoring
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: KY20192104-X-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No