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Trial record 3 of 8 for:    "Bipolar Disorder" | "Cycloserine"

Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869765
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : September 10, 2010
Information provided by:
The University of New South Wales

Brief Summary:
Among antidepressant treatments, Electroconvulsive therapy (ECT) stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). The investigators' current study of tDCS as a treatment for depression suggests that this technique has antidepressant effects and is safe, painless and well tolerated. However, not all patients may respond to this treatment and the concern of possible relapse in some patients who respond to tDCS has raised interest in finding treatments that may enhance and prolong the antidepressant effects of tDCS. This study will investigate whether D-Cycloserine, a medication shown to lengthen the effects of tDCS on brain activity, can also enhance/prolong the antidepressant effects of tDCS in people suffering from depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar Disorder Drug: D-Cycloserine Device: tDCS (Eldith DC-Stimulator (CE certified)) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) Augmented by D-Cycloserine as a Treatment for Depression.
Study Start Date : April 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: tDCS and D-CYC
Major Depression tDCS and D-cyc
Drug: D-Cycloserine
100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.

Device: tDCS (Eldith DC-Stimulator (CE certified))
tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Other Name: Eldith DC-Stimulator (CE certified)

Primary Outcome Measures :
  1. Inventory of Depressive Symptomatology (IDS-C) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
  2. Subject completed study HREC 07305.
  3. Subject either did not reach remission at the end of trial (defined as MADRS score of ≤ 10) or suffered an early relapse (within a month of finishing the trial).

Exclusion Criteria:

  1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder current or within the past year); mental retardation.
  2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  3. Inadequate response to ECT in the current episode of depression.
  4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
  7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  8. Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869765

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Australia, New South Wales
Black Dog Institute, University of New South Wales
Randwick, New South Wales, Australia, 2032
Sponsors and Collaborators
The University of New South Wales
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Principal Investigator: Colleen Loo University of New South Wales

Additional Information:
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Responsible Party: Associate Professor Colleen Loo, University of New South Wales Identifier: NCT00869765     History of Changes
Other Study ID Numbers: 09052
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010
Keywords provided by The University of New South Wales:
Transcranial direct current stimulation
Additional relevant MeSH terms:
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Bipolar Disorder
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action