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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00481026
Ethics application status
Date submitted
30/05/2007
Date registered
1/06/2007
Date last updated
9/05/2008

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] 0 0
11707
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Major Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
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] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Scales
Timepoint [1] 0 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Other
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/show/NCT00481026
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP
Address 0 0
Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 6552
Fax 0 0
Email 0 0
p.fitzgerald@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00481026