NCT01516931

Brief Summary

The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2017

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

December 29, 2011

Last Update Submit

January 8, 2020

Conditions

Depression

Keywords

repetitive Transcranial Magnetic Stimulation (rTMS)DepressionVenlafaxineRelapse

Outcome Measures

Primary Outcomes (1)

  • Time for relapse

    Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period

    Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 weeks

Secondary Outcomes (3)

  • Hamilton Depression Rating Scale

    baseline and 15 months

  • Illness severity change

    baseline and 15 months

  • subject functioning

    baseline and 15 months

Study Arms (3)

active rTMS and venlafaxine

EXPERIMENTAL

rTMS：Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. venlafaxine：150-225mg/day

Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)

sham rTMS and venlafaxine

PLACEBO COMPARATOR

Sham stimulation will be given at the same site and frequency, using a Magstim sham-coil system. During rTMS, participants will be instructed to keep their eyes open and relax.

Behavioral: counseling

venlafaxine alone

PLACEBO COMPARATOR

responders will be maintained on the same effective dose of venlafaxine for the entire duration of the RCT, unless they relapse and will have to exit the protocol and enter a naturalistic follow-up

Behavioral: counseling

Interventions

repetitive Transcranial Magnetic Stimulation (rTMS)PROCEDURE

1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks

active rTMS and venlafaxine
counselingBEHAVIORAL

Placebo monthly by general counseling for 12 months.

sham rTMS and venlafaxinevenlafaxine alone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of depression
  • Experiencing an acute exacerbation of depression symptoms
  • Baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
  • Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements

You may not qualify if:

  • Comprised ferromagnetic metallic implants
  • Pacemakers
  • Previous neurosurgery
  • History of seizures
  • Major head trauma
  • Alcoholism
  • Drug addiction
  • Any psychiatric or neurological disorder other than depression and anxiety
  • Psychotic depression
  • Suicidal propensities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingrong

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Wang H, Xue Y, Chen Y, Zhang R, Wang H, Zhang Y, Gan J, Zhang L, Tan Q. Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial. Trials. 2013 Oct 17;14:338. doi: 10.1186/1745-6215-14-338.

    PMID: 24135054DERIVED

MeSH Terms

Conditions

DepressionRecurrence

Interventions

Transcranial Magnetic StimulationCounseling

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: rTMS intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of department

Study Record Dates

First Submitted

December 29, 2011

First Posted

January 25, 2012

Study Start

January 1, 2013

Primary Completion

December 30, 2016

Study Completion

February 25, 2017

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

CN(1)