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Effectiveness of Escitalopram-Tandospirone Citrate in Patients with Vascular Depression Accompanied by Mild Cognitive Decline: A Pilot Randomized Controlled Trial at a Single-Center in China

Effectiveness of Escitalopram-Tandospirone Citrate in Patients with Vascular Depression Accompanied by Mild Cognitive Decline: A Pilot Randomized Controlled Trial at a Single-Center in China

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051241
Enrollment
Unknown
Registered
2021-09-16
Start date
2017-10-01
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Vascular depression

Interventions

Combined therapy group :Escitalopram 10 mg once daily, and 5 mg of Tandospirone Citrate three times per day in Week 1
from Week 2, Tandospirone Citrate was increased to 10 mg per time and administered three times per day.
Monotherapy group:Escitalopram 10 mg once daily.

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Diagnosis according to the diagnosis standard for the first or repeated episodes of depression in the Diagnostic and Statistical Manual of Mental Disorders Edition IV (DSM-IV) issued by the American Psychiatric Association. 2.Diagnosis according to the diagnosis standard for vascular depression recommended by Alexopoulos. 3.Score over 17 points in Hamilton Depression Rating Scale (HAMD). 4.Score of 14 points or more in Hamilton Anxiety Scale (HAMA). 5.Score between 17 and 26 points (exclusive) in Montreal Cognitive Assessment (MoCA). 6.A clear mind and self-care ability, and capability of answering almost all scales independently.

Exclusion criteria

Exclusion criteria: 1. Current psychological diseases other than depression and anxiety. 2. Other nerve system diseases such as epilepsy, Alzheimer's disease, Parkinson's disease and intracranial tumor. 3. Severe or unstable physical diseases such as heart, liver, kidney, endocrine, blood and respiratory diseases. 4. Allergy to Escitalopram or Tandospirone Citrate. 5. High suicide risk, with a score over 30 points in the Suicide Assessment Scale (SUAS). 6. Proven alcohol or drug dependence, with a score of 5 points or more in the Michigan Alcoholism Screening Test (MAST). 7. Poor medication adherence, with a score of less than 6 points in the Morisky Medication Adherence Scale-8 (MMAS-8). 8. Inability to undergo head MRI scan. 9. Severe visual or hearing impairment or severe aphasia or limb dysfunction that might affect examinations. 10. Participation in other clinical studies in the past 30 days.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale(HAMD);Hamilton Anxiety Scale (HAMA);

Secondary

MeasureTime frame
Rey Auditory Verbal Learning Test (RAVLT);Verbal Fluency Test (VFT);Trail Making Test (TMT);Digital Span Test (DST);Clock Draw Test (CDT);Clinical Global Impression (CGI);

Countries

China

Contacts

Public ContactYingchun Xiao

Fujian Medical University Union Hospital

13365910685@163.com+86 13365917986

Outcome results

None listed

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