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

NCT00481026 | Completed

• 1 other identifier: 11707
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Schizophrenia; Major Depression

Outcome Measures

Primary Outcomes (1)

• Clinical Scales

  3 weeks

Study Arms (2)

Placebo

SHAM COMPARATOR

Placebo tDCS

Device: transcranial direct current stimulation (tDCS)

active tDCS

ACTIVE COMPARATOR

active tDCS

Device: active tDCS

Interventions

transcranial direct current stimulation (tDCS) DEVICE

tDCS

Placebo

active tDCS DEVICE

Active tDCS

active tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schizophrenia
• Participants will be included if they:
• Are voluntary and competent to consent;
• Have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV)
• Have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
• are between the ages of 18 and 65.
• Concomitant medications including:
• Benzodiazepines,
• Mood stabilizers (lithium, valproic acid)
• Depression
• Participants will be included if they:
• Are competent to consent;
• 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);
• 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
• Are between the ages of 18 and 75.

You may not qualify if:

• Patients will be excluded if they:
• Have a DSM-IV history of substance abuse or dependence in the last 6 months;
• Have a concomitant major and unstable medical or neurologic illness;
• Are currently taking carbamazepine; or,
• Are pregnant.
• Patients will be withdrawn from the study if they:
• Withdraw consent;
• Experience significant clinical deterioration;
• Fail to tolerate the procedure; or,
• 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.

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Psychiatry Research Centre

Prahran, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP

  Alfred Psychiatry Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

AU (1)