Clinical study of venlafaxine hydrochloride combined with tandospirone citrate in the treatment of vascular depression with somatization symptoms

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048442

Enrollment

Unknown

Registered

2021-07-07

Start date

2017-10-01

Completion date

Unknown

Last updated

2022-03-21

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

Conditions

Vascular depression

Interventions

Venlafaxine group:Venlafaxine hydrochloride 75mg, once a day, if there are no adverse drug events, adjust to 150mg once a day in the second week.

Combination Therapy Group:Venlafaxine hydrochloride 75mg, once a day, if there is no adverse drug event, adjust to 150mg once a day in the second week, and add tandospirone citrate 5mg once a day at t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for the first or recurrence of depression in the Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV); (2) Meet the diagnostic criteria for vascular depression proposed by Alexopoulos; (3) Hamilton Depression Rating Scale (HAMD) score> 17 points; (4) Hamilton Anxiety Scale (HAMA) score >= 14 points; (5) 15 items of patient health questionnaire (PHQ-15) score >=5 points; (6) Clear consciousness, able to independently complete various neurological scales.

Exclusion criteria

Exclusion criteria: (1) Accompanied by serious medical diseases such as heart, liver, kidney and respiratory diseases; (2) Accompanied by other neurological diseases such as Alzheimer's disease, Parkinson's disease, intracranial tumors, etc.; (3) Unable to complete head MRI examination; (4) Allergy to venlafaxine or tandospirone; (5) Suicide Assessment Scale (SUAS) rated as a high risk of suicide (score> 30 points); (6) Michigan Alcoholism Screening Test (MAST) confirmed that there is alcohol or drug dependence (score >=5 points); (7) Participated in other clinical studies in the last 30 days; (8) The medication compliance was assessed by the Medication Compliance Scale-8 (MMAS-8) (score <6 points).

Design outcomes

Primary

Measure	Time frame
Psychological condition;Decrease rate of each scale score after treatment;	—

Secondary

Measure	Time frame
CGI score and percentage of recovery;Plasma serotonin;Plasma norepinephrine;Plasma dopamine;Platelet serotonin;	—

Countries

China

Contacts

Public ContactYingchun Xiao

Union Hospital, Fujian Medical University

13365910685@163.com+86 13365917986

Outcome results

None listed

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