Clinical trial NCT02472613: Acupuncture for Ischemic Post-stroke Depression
Official title: Comparison of Acupuncture and Fluoxetine for of Ischemic Post-stroke Depression：A Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Depression
Keywords: Post-Stroke Depression
Acupunture
Fluoxetine
RCT
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: State Administration of Traditional Chinese Medicine of the People's Republic of China
name: Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital
name: Beijing Hospital of Traditional Chinese Medicine
First posted: 2015-06-16
Enrollment: 208
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 17-item Hamilton Depression Scale( HAMD-17)
timeFrame: 12 weeks
measure: Barthel Index (BI)
timeFrame: 12 weeks
measure: Clinical Global Impression (CGI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-Rating Depression Scale(SDS)
timeFrame: 12 weeks
measure: Treatment Emergent Symptom Scale,(TESS )
timeFrame: 12 weeks
measure: Stroke diagnosis and evaluation criteria of Traditional Chinese Medicine（TCM）
timeFrame: 12 weeks
Other outcomes:
measure: Ratio of NAA/Cr，Cho/Cr，mI/Cr by Magnetic Resoance Spectroscopy(MRS)
timeFrame: 12 weeks
measure: Determination of the content change of cytokines IL-1β, IL-6, TNF-α, BDNF in plasma
timeFrame: 12 weeks
Locations:
city: Tianjin
country: China
facility: First Affiliated hospital of Tianjin University of TCM
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Academy of Tradional Chinese Medicine Afflicated Hospital
state: Tianjin
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
Study officials:
References: