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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Major Depression	Device: transcranial direct current stimulation (tDCS); Device: active tDCS	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression
Study Start Date :	July 2007
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	December 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: Placebo; Placebo tDCS	Device: transcranial direct current stimulation (tDCS); tDCS
Active Comparator: active tDCS; active tDCS	Device: active tDCS; Active tDCS

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Clinical Scales [ Time Frame: 3 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP	+61 3 9076 6552 ext 66552	p.fitzgerald@alfred.org.au
Contact: Kate E Hoy, BBNSci(Hons)	+61 3 9076 5030 ext 65030	k.hoy@alfred.org.au

Locations

Australia, Victoria
Alfred Psychiatry Research Centre	Recruiting
Prahran, Victoria, Australia, 3181

Sponsors and Collaborators

Bayside Health

Investigators

Principal Investigator:	Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP	Alfred Psychiatry Research Centre

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Professor Paul Fitzgerald, Alfred Psychiatry Research Centre
ClinicalTrials.gov Identifier:	NCT00481026 History of Changes
Other Study ID Numbers:	11707
First Posted:	June 1, 2007
Last Update Posted:	May 9, 2008
Last Verified:	May 2007

Additional relevant MeSH terms:

Depression; Depressive Disorder; Schizophrenia; Depressive Disorder, Major	Behavioral Symptoms; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders