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

NCT ID: NCT04207385

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-11-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Keywords

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pharmacogenomics PGx therapeutic drug monitoring TDM Venlafaxine depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A group: Routine treatment group

Routine dosage of venlafaxine during the first 4 weeks.

Group Type ACTIVE_COMPARATOR

Venlafaxine

Intervention Type DRUG

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

B group: PGx-guided group

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

Group Type EXPERIMENTAL

pharmacogenomics

Intervention Type DIAGNOSTIC_TEST

pharmacogenomics

Venlafaxine

Intervention Type DRUG

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

C group: Routine PGx-guided group

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

Group Type ACTIVE_COMPARATOR

pharmacogenomics

Intervention Type DIAGNOSTIC_TEST

pharmacogenomics

Venlafaxine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

pharmacogenomics

Intervention Type DIAGNOSTIC_TEST

pharmacogenomics

pharmacogenomics & therapeutic drug monitoring

Intervention Type DIAGNOSTIC_TEST

pharmacogenomics \& therapeutic drug monitoring

Venlafaxine

Intervention Type DRUG

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

Interventions

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pharmacogenomics

pharmacogenomics

Intervention Type DIAGNOSTIC_TEST

pharmacogenomics & therapeutic drug monitoring

pharmacogenomics \& therapeutic drug monitoring

Intervention Type DIAGNOSTIC_TEST

Venlafaxine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huaning Wang

Role: STUDY_CHAIR

Deputy Chief Physician

Ping Zhou

Role: PRINCIPAL_INVESTIGATOR

Attending Physician

Yihuan Chen

Role: PRINCIPAL_INVESTIGATOR

Attending Physician

Huizhen Lu

Role: PRINCIPAL_INVESTIGATOR

Resident Physician

Qinghong Yan

Role: PRINCIPAL_INVESTIGATOR

Nurse

Locations

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Xijing Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huaning Wang

Role: CONTACT

Phone: +86 13609161341

Email: [email protected]

Facility Contacts

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Huaning Wang

Role: primary

Other Identifiers

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KY20192104-X-1

Identifier Type: -

Identifier Source: org_study_id