Acupuncture for Ischemic Post-stroke Depression

Tianjin University of Traditional Chinese Medicine

Status: Completed

Conditions: Post-stroke Depression

Treatments: Drug: placebo; Device: sham-acupoint acupuncture; Device: acupuncture; Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT02472613

201407001-6B

Details and patient eligibility

About

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.

Full description

Aim: To observe the curative effect of acupuncture in the treatment of Ischemic Post-Stroke Depression． Design: A multicentre,open-label randomized controlled trial will be performed in Tianjin and Beijing . Two hundred and eight participants with Ischemic Post-Stroke Depression patients were randomly divided into two groups which were both given basic treatment of stroke. The acupuncture group was given Tiaoshenkaiqiao acupuncture therapy and placebo，while the control group was treated with fluoxetine tablets and sham acupoint acupuncture treatment. Evaluated the clinical efficacy of the two groups with Hamilton Depression Scale(HAMD), Barthel Index (BI),Treatment Emergent Symptom Scale,(TESS ),Clinical Global Impression Scale(CGI) respectively before treatment, the second weekend of treatment ,the fourth weekend of treatment, the eighth weekend of treatment, the twelfth weekend of treatment. And observed the adverse reaction of the two groups.

Each participants will receive 36 sessions of acupuncture in 12 weeks, with a duration of 30 minutes in a session. After all the treatments were accomplished, there will be one follow-ups in the 24th week.

Enrollment: 208 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

traditional acupuncture & placebo

Experimental group

Description:

Apply traditional acupuncture to treat the ischemic post-stroke depression according to TCM theory.

Treatment:

Device: acupuncture

Drug: placebo

sham-acupoint acupuncture & fluoxetine

Active Comparator group

Description:

Fluoxetine was given at a dose of 20 mg/day. sham-acupoint will be penetrated for treat the ischemic post-stroke depression.

Treatment:

Device: sham-acupoint acupuncture

Drug: Fluoxetine