NCT01974076

Brief Summary

This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

October 27, 2013

Last Update Submit

December 2, 2014

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    3 weeks

Secondary Outcomes (1)

  • Depression and Anxiety Stress Scale

    3 weeks

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR
Device: Active tDCS + CBT

Sham tDCS

SHAM COMPARATOR
Device: Sham tDCS + CBT

Interventions

Active tDCS + CBTDEVICE
Active tDCS
Sham tDCS + CBTDEVICE
Sham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be ≥ 18 years old.
  • Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.
  • MADRS score ≥ 20 at study entry.

You may not qualify if:

  • Participant is unable to give informed consent.
  • DSM-IV diagnosis of psychotic disorder (lifetime).
  • Bipolar disorder diagnosis and not on a mood stabiliser.
  • Eating disorder (current or within past year).
  • Obsessive compulsive disorder (lifetime).
  • Post-traumatic stress disorder (current or within past year).
  • Mental retardation.
  • Drug or alcohol abuse or dependence (preceding 3 months).
  • Inadequate response to ECT (current episode of depression).
  • Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
  • Clinically defined neurological disorder or insult.
  • Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Pregnancy.
  • Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
  • Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belmont Private Hospital

Carina, Brisbane, Queensland, 4152, Australia

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Sandy Sacre

CONTACT

sandy.sacre@healthecare.com.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 1, 2013

Study Start

May 1, 2014

Primary Completion

September 1, 2018

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

AU(1)