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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression
Scientific title
An Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) Augmented by D-Cycloserine as a Treatment for Depression.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Mental Health 0 0 0 0
Other mental health disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - D-Cycloserine
Treatment: Devices - tDCS (Eldith DC-Stimulator (CE certified))

Experimental: tDCS and D-CYC - Major Depression tDCS and D-cyc

Treatment: Drugs: D-Cycloserine
100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.

Treatment: Devices: 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).

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Inventory of Depressive Symptomatology (IDS-C)
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Timepoint [1] 0 0
6 months

Key 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).
Minimum age
18 Years
Maximum age
90 Years
Both males and females
Can healthy volunteers participate?
Key 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

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)

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Black Dog Institute, University of New South Wales - Randwick
Recruitment postcode(s) [1] 0 0
2032 - Randwick

Funding & Sponsors
Primary sponsor type
The University of New South Wales

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Colleen Loo
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications