Acupuncture for Ischemic Post-stroke Depression

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicentre, single Blind ,randomized controlled clinical trial in ischemic post-stroke depression patients.The participants will be allocated randomly in either of the two groups: verum acupuncture plus placebo medication group or sham acupuncture plus true medication group. On the hypothesis that acupuncture intervention could produce the same therapeutic effects as antidepressants. The investigators also hypothesized that acupuncture would be associated with minimal side effects.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; Menghan Li
• Collaborators: Beijing Hospital of Traditional Chinese Medicine; State Administration of Traditional Chinese Medicine of the People's Republic of China; Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• in accordance with diagnosis of ischemic stroke in International Classification of Diseases-10 163, （ICD-10 163）;

• diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-IV （DSM-IV）or Chinese Classification and Diagnostic Criteria of Mental Disorders-3(CCMD-3)

• age of a subject is between 40 and 80 years old, male or female;

• most recently experience an ischemic post-stroke depression and recent (<6 months);

• conscious, examination cooperation, without aphasia and severe cognitive impairment;

• capacity to provide written consent for both research assessment and treatment.

Exclusion Criteria:

• participation in any clinical trial within the previous or taking antidepressant treatment 2 weeks prior to baseline;

• presence of severe cognitive dysfunction, indicated the Mini-mental State Examination (MMSE) score of < 17

• presence of severe aphasia;

• had a history of psychiatric illness or depression

• impaired hepatic , renal function., hematological systems and so on;

• those who can not cooperate with treatment;

• pregnant women or women in lactation

• presence of another chronic disorder, including chronic alcoholism or durg abuse