NCT00869765

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 10, 2010

Status Verified

September 1, 2010

Enrollment Period

1.4 years

First QC Date

March 25, 2009

Last Update Submit

September 9, 2010

Conditions

Major Depressive DisorderBipolar Disorder

Keywords

DepressionTreatmentTranscranial direct current stimulationD-cycloserine

Outcome Measures

Primary Outcomes (1)

  • Inventory of Depressive Symptomatology (IDS-C)

    6 months

Secondary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    6 months

Study Arms (1)

tDCS and D-CYC

EXPERIMENTAL

Major Depression tDCS and D-cyc

Drug: D-CycloserineDevice: tDCS (Eldith DC-Stimulator (CE certified))

Interventions

D-CycloserineDRUG

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

tDCS and D-CYC
tDCS (Eldith DC-Stimulator (CE certified))DEVICE

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)
tDCS and D-CYC

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject completed study HREC 07305.
  • 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).

You may not qualify if:

  • 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.
  • History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  • Inadequate response to ECT in the current episode of depression.
  • Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  • Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  • Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
  • Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Dog Institute, University of New South Wales

Randwick, New South Wales, 2032, Australia

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderDepression

Interventions

CycloserineTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsElectric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Colleen Loo

    University of New South Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 10, 2010

Record last verified: 2010-09

Locations

AU(1)