Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)

NCT ID: NCT01974076

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Brief Summary

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

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active tDCS

Group Type ACTIVE_COMPARATOR

Active tDCS + CBT

Intervention Type DEVICE

Sham tDCS

Group Type SHAM_COMPARATOR

Sham tDCS + CBT

Intervention Type DEVICE

Interventions

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Active tDCS + CBT

Intervention Type DEVICE

Sham tDCS + CBT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belmont Private Hospital

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Colleen Loo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Belmont Private Hospital

Carina, Brisbane, Queensland, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Sandy Sacre

Role: CONTACT

Facility Contacts

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Sandy Sacre

Role: primary

Other Identifiers

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HC13276

Identifier Type: -

Identifier Source: org_study_id