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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00481026

Registration number

NCT00481026

Ethics application status

Date submitted

30/05/2007

Date registered

1/06/2007

Date last updated

14/10/2020

Titles & IDs

Public title

A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression

Scientific title

A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression

Secondary ID [1]

11707

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Schizophrenia

Major Depression

Condition category

Condition code

Mental Health

Depression

Mental Health

Schizophrenia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Devices - transcranial direct current stimulation (tDCS)
Treatment: Devices - active tDCS

Sham comparator: Placebo - Placebo tDCS

Active comparator: active tDCS - active tDCS

Treatment: Devices: transcranial direct current stimulation (tDCS)
tDCS

Treatment: Devices: active tDCS
Active tDCS

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Clinical Scales

Timepoint [1]

3 weeks

Eligibility

Key inclusion criteria

* Schizophrenia
* Participants will be included if they:

1. Are voluntary and competent to consent;
2. Have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV)
3. Have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
4. are between the ages of 18 and 65.
* Concomitant medications including:

1. Benzodiazepines,
2. Mood stabilizers (lithium, valproic acid)
3. Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.
* Depression
* Participants will be included if they:

1. Are competent to consent;
2. Have a diagnosis of Major Depression and are currently experiencing a Major Depressive Episode as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV);
3. Are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
4. Are between the ages of 18 and 75.
* Concomitant medications including:

1. Benzodiazepines,
2. Mood stabilizers (lithium, valproic acid)
3. Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Patients will be excluded if they:

1. Have a DSM-IV history of substance abuse or dependence in the last 6 months;
2. Have a concomitant major and unstable medical or neurologic illness;
3. Are currently taking carbamazepine; or,
4. Are pregnant.
* Patients will be withdrawn from the study if they:

1. Withdraw consent;
2. Experience significant clinical deterioration;
3. Fail to tolerate the procedure; or,
4. Develop a serious adverse event. In the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/08/2007

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/05/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Alfred Psychiatry Research Centre - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia and patients with depression. tDCS involves the application of an extremely weak continuous electrical current to the brain through the placement of anode and a cathode on the scalp. The electrical current is generally completely imperceptible after initial period of tingling which takes about 30 seconds. Stimulation under the anode appears to increase brain activity where as stimulation under the cathode has the opposite effect. This research plan involves two clinical trials:

1. A study using tDCS to treat both the positive and negative symptoms of schizophrenia. The negative symptoms of schizophrenia such as lack of motivation and energy appear to arise due to a lack of activity in frontal brain areas. Positive symptoms such as hallucinations and confused thoughts may arise through over activity of brain areas more on the side and towards the back of the brain called the temporal cortex. We plan to apply tDCS such that it can simultaneously increased activity in these frontal brain areas and reduce activity over temporal cortex. We will compare active stimulation to a placebo condition which involves turning the stimulator off after 30 seconds. The capacity to target multiple symptom clusters is unique with this type of brain stimulation.
2. The study using tDCS in treatment resistant depression builds on a work with transcranial magnetic stimulation (TMS). TMS techniques in depression seem to work which increased left frontal brain activity or decrease right frontal brain activity. tDCS will be used to do the same thing with the anode used to increase left-sided brain activity and the cathode used to simultaneously decreased right-sided brain activity.

tDCS is potentially a better tolerated procedure than TMS and does not appear to have the same risk of seizure induction. Importantly, the equipment is quite inexpensive and this may prove to be an extremely safe and effective low-cost treatment for psychiatric disorders in Third World countries.

Trial website

https://clinicaltrials.gov/study/NCT00481026

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP

Address

Alfred Psychiatry Research Centre

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00481026

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00481026