Acupuncture and Escitalopram for Treating Major Depression Clinical Study

ConditionDepressive Disorder, Major

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai 7th People's Hospital

About this trial

We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between 18 and 75 years of age with no gender-based restriction.

Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.

A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17

Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.

Disqualifiers

Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.

High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.

Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.

Pregnancy or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

acupuncture
Other intervention
The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include DU20（Baihui) and SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation.
escitalopram
Other intervention
Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
sham-acupuncure
Other intervention
In the sham acupuncture group, superficial skin penetration (2 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group.
escitalopram placebo
Other intervention
Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.

Treatment groups

216 Participants

are divided into 4 treatment groups

Group A: sham-acupuncture/placebo-pillSham comparator 2 interventions

Group B: sham-acupuncture/escitalopramActive comparator 2 interventions

Group C: active acupuncture/placebo-pillActive comparator 2 interventions

Group D: active acupuncture/escitalopramExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

HDRS-17 scale

the change in the HDRS-17 score

Time frame

from baseline to 10 weeks

Secondary outcomes

Beck depression inventory scale

the change in the Beck depression inventory score

Time frame

from baseline to 10 weeks

The CGI(Clinical Global Impression) scale

the change in the CGI

Time frame

from baseline to 10 weeks

The GAD-7(General Anxiety Disorder) scale

the change in the GAD-7

Time frame

from baseline to 10 weeks

The Mini-Mental State Examination (MMSE) scale

the change in the MMSE

Time frame

from baseline to 10 weeks

Other outcomes

BDNF

serum BDNF level

Time frame

at baseline and 10 week

IL18/IL-1β

serum IL18/IL-1β level

Time frame

at baseline and 10 week

fMRI

functional MRI

Time frame

at baseline and 10 week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai 7th People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: