DepressionNCT01974076
Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)
A study testing Active tDCS + CBT in people with Depression, run by The University of New South Wales at 1 site in Australia.
Trial summary
This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Active tDCS + CBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteAustralia
- Study dates
- May 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Participant becomes hypomanic or manic, as defined by DSM-IV.
Trial locations and contacts
1 site in 1 country.
Sandy Sacre contact
Australia1 site, 1 recruiting
- Recruiting
Belmont Private Hospital
Carina, Brisbane, Queensland, 4152
Sandy Sacre, sandy.sacre@healthecare.com.au
Sandy Sacre
About this study
Official title: A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression
This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.
- Conditions
- Depression
- Being tested
- Active tDCS + CBT, Sham tDCS + CBT
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS + CBTDevice
Sham tDCS + CBTDevice
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Not described Receives: Device: Active tDCS + CBT |
| Sham tDCS | Sham comparator | Not described Receives: Device: Sham tDCS + CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Measured: 3 weeks
Secondary outcomes (1)
Depression and Anxiety Stress Scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Belmont Private Hospital
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974076
- Sponsor's protocol ID
- HC13276
- Status last verified
- Dec 2014
- First submitted
- 27 Oct 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression
- ClinicalTrials.gov ID
- NCT01974076
- Acronym / sponsor ID
- HC13276
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Belmont Private Hospital
- Study start
- May 2014
- Primary completion
- Sep 2018 (estimated)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Active tDCS + CBT |
| Sham tDCS | Sham comparator | Device: Sham tDCS + CBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCS + CBT | Device | Active tDCS |
| Sham tDCS + CBT | Device | Sham tDCS |
Primary outcome
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time frame: 3 weeks
1 secondary outcome
Depression and Anxiety Stress Scale
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandy Sacre contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS + CBT in people with Depression, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Sacre (sandy.sacre@healthecare.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale for Depression (MADRS) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.