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CompletedNCT00869765Updated Sep 10, 2010

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

A Phase 2 interventional study of D-Cycloserine and tDCS (Eldith DC-Stimulator (CE certified)) in Major Depressive Disorder and Bipolar Disorder, sponsored by The University of New South Wales. Completed at 1 site in Australia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-09-10.

Sponsored by The University of New South Wales · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder
  • Bipolar Disorder

Keywords

  • Depression
  • Treatment
  • Transcranial direct current stimulation
  • D-cycloserine
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In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 5 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

The University of New South Wales is the lead sponsor of 65 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    tDCS and D-CYC

    Major Depression tDCS and D-cyc

    Drug: D-Cycloserine · Device: tDCS (Eldith DC-Stimulator (CE certified))

Interventions

  • DrugD-Cycloserine

    100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.

  • DevicetDCS (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).

    Also known as: Eldith DC-Stimulator (CE certified)

06

What researchers measure

Primary outcomes

  1. Inventory of Depressive Symptomatology (IDS-C)

    Time frame: 6 months

Secondary outcomes

  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    Time frame: 6 months

07

Study locations

1 site
  • Black Dog Institute, University of New South Wales
    Randwick, New South Wales 2032, Australia
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00869765
Lead sponsor
The University of New South Wales
First posted
Mar 26, 2009
Start date
Apr 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 10, 2010

Study contacts

Colleen Loo
principal investigator · University of New South Wales

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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