Electroacupuncture Combined With Antidepressants for Post-stroke Depression
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| ClinicalTrials.gov Identifier: NCT01174394 |
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Recruitment Status :
Completed
First Posted : August 3, 2010
Last Update Posted : May 1, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression Stroke | Procedure: DCEAS (Hwato®/ Dongbang®) Procedure: Body electro-acupuncture (Hwato®/ Dongbang®) Procedure: n-CEA (Strietberger®) Drug: Fluoxetine | Not Applicable |
Mood depression is a common and serious consequence of stroke. A large proportion of stroke patients develop post-stroke depression (PSD), either in the early or late stages after stroke. Although antidepressant agents, represented by selective serotonin reuptake inhibitors (SSRIs), are recommended as first-line drugs in pharmaco-therapy of PSD, its effectiveness is limited and the clinical use is largely hampered due to broad side effects, especially on cardiovascular system. In addition, since stroke patients are often medicated with various classes of drugs, the addition of antidepressant agents may increase risk of drug-drug interactions, resulting in unexpected and unpredictable adverse events.
The objective of this proposed study is to determine whether electro-acupuncture (EA) combined with antidepressants could produce significantly greater improvement on depressive symptoms in patients with PSD compared to antidepressants alone.
In this 4-week, assessor-blind, randomized, controlled study of electro-acupuncture (EA) as additional treatment with the antidepressant drug called fluoxetine (FLX), a total of 60 patients with post-stroke depression (PSD) will be recruited. The patients will be randomly assigned to FLX (10-30 mg/day) combined with active cranial and body acupuncture (n =30) or FLX with placebo cranial and active body acupuncture (n =30) (12 sessions, 3 sessions a week). Changes in the severity of depressive symptoms over time are measured using depressive scale instruments. Clinical response and remission rates are also calculated. The study will be conducted at HKU School of Chinese Medicine, Tung Wah Hospital, and Kowloon Hospital, Hong Kong.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Assessor-blind, Controlled Trial of Electroacupuncture Combined With Antidepressants in Treating Patients With Post-stroke Depression |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: DCEAS
Body electroacupuncture plus dense cranial electroacupuncture stimulation (DCEAS) For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day. |
Procedure: DCEAS (Hwato®/ Dongbang®)
Upon insertion of acupuncture needles, dense cranial electro-acupuncture stimulation (DCEAS), is directly delivered on a density of cranial acupoints (in general 6-8 pairs) located on the frontal, parietal, and temporal scalp areas.
Other Names:
Procedure: Body electro-acupuncture (Hwato®/ Dongbang®) Both study arms received body electroacupuncture on both sides of ipsilateral limb pairs: Hegu (LI4) and Quchi (LI11) , Zusanli (ST36) and Taichong (LR3). Electrical stimulation as DCEAS is applied.
Other Names:
Drug: Fluoxetine Subjects of both study arms received orally administered SSRIs for 4 weeks in an open manner. For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.
Other Names:
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Placebo Comparator: n-CEA
Body electroacupuncture plus non-invasive cranial electroacupuncture (n-CEA) For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day. |
Procedure: Body electro-acupuncture (Hwato®/ Dongbang®)
Both study arms received body electroacupuncture on both sides of ipsilateral limb pairs: Hegu (LI4) and Quchi (LI11) , Zusanli (ST36) and Taichong (LR3). Electrical stimulation as DCEAS is applied.
Other Names:
Procedure: n-CEA (Strietberger®) Streitberger's non-invasive acupuncture needles were applied to serve as sham control at the same cranial acupoints and the same stimulation modality, except that the needles only adhere to the skin instead of insertion
Other Name: Strietberger® Drug: Fluoxetine Subjects of both study arms received orally administered SSRIs for 4 weeks in an open manner. For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.
Other Names:
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- HAMD-17, GDS , BI and CGI [ Time Frame: 28-day (course of treatment) ]Depression symptoms are primarily measured using the 17-item Hamilton Depression Scale (HAMD-17) and Geriatric Depression Scale (GDS); physical outcomes will be measured using Barthel Index (BI); Clinical Global Impression (CGI) would also be measured by clinician. The measurements are carried out at the baseline, first, second and fourth week of treatment course.
- Clinical response, latency and adverse events [ Time Frame: 28-day (course of treatment) ]
The secondary efficacy measures include clinical response, defined as greater than or equal to 50% reduction at endpoint from baseline on HAMD-17; remission, defined as 7 points or less on HAMD-17 score; and the latency of the clinical response. The measurements are carried out at the baseline, first, second and fourth week of treatment course.
Adverse events are assessed using the Treatment Emergent Symptom Scale (TESS) when applicable.
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| Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- most recently experience an ischemic or hemorrhagic stroke, documented by cerebral computed topographic scanning or magnetic resonance imaging
- develop significant depression, with a HAMD-17 score of 16 or greater
Exclusion Criteria:
- presence of severe aphasia, especially fluent aphasia
- presence of severe cognitive dysfunction, indicated the Mini-mental State Examination (MMSE) score of < 18
- had a history of psychiatric illness other than depression
- presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism
- impaired hepatic or renal function
- have bleeding tendency
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174394
| Hong Kong | |
| Tung Wah Hospital - Rehabilitation Unit, Department of Medicine | |
| Hong Kong, Hong Kong | |
| Kowloon Hospital - Department of Psychiatry | |
| Kowloon, Hong Kong | |
| Kowloon Hospital - Department of Rehabilitation | |
| Kowloon, Hong Kong | |
| Principal Investigator: | Zhang-Jin Zhang, MMed, PhD | The University of Hong Kong |
| Responsible Party: | Prof. Zhang Zhang-Jin, Professor, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01174394 |
| Other Study ID Numbers: |
UW 10-211 |
| First Posted: | August 3, 2010 Key Record Dates |
| Last Update Posted: | May 1, 2013 |
| Last Verified: | April 2013 |
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Acupuncture Post Stroke Depression Depressive Disorder Cardiovascular Accident |
Stroke Apoplexy CVA |
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Stroke Depression Depressive Disorder Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Behavioral Symptoms Mood Disorders Mental Disorders Fluoxetine |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |