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

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ClinicalTrials.gov Identifier: NCT00869765
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:
The University of New South Wales

Tracking Information
First Submitted Date  ICMJE March 25, 2009
First Posted Date  ICMJE March 26, 2009
Last Update Posted Date September 10, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Inventory of Depressive Symptomatology (IDS-C) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2009)
Inventory of Depressive Symptomatology (IDS-C) [ Time Frame: Baseline (pre-treatment), post 10 and 20 D-cyc & tDCS sessions, and follow-up 1 month and 6 months post treatment ]
Change History Complete list of historical versions of study NCT00869765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2009)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: Baseline (pre-treatment), post 10 and 20 D-cyc & tDCS sessions, and follow up 1 month and 6 months post treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression
Official Title  ICMJE An Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) Augmented by D-Cycloserine as a Treatment for Depression.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Bipolar Disorder
Intervention  ICMJE
  • 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)
Study Arms  ICMJE Experimental: tDCS and D-CYC
Major Depression tDCS and D-cyc
Interventions:
  • Drug: D-Cycloserine
  • Device: tDCS (Eldith DC-Stimulator (CE certified))
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2010)
5
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2009)
20
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00869765
Other Study ID Numbers  ICMJE 09052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Associate Professor Colleen Loo, University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Colleen Loo University of New South Wales
PRS Account The University of New South Wales
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP