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

Primary Purpose

Major Depressive Disorder, Bipolar Disorder

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

D-Cycloserine

tDCS (Eldith DC-Stimulator (CE certified))

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Treatment, Transcranial direct current stimulation, D-cycloserine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
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).

Exclusion Criteria:

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)

Sites / Locations

Black Dog Institute, University of New South Wales

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS and D-CYC

Arm Description

Major Depression tDCS and D-cyc

Outcomes

Primary Outcome Measures

Inventory of Depressive Symptomatology (IDS-C)

Secondary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Full Information

NCT ID

NCT00869765

First Posted

March 25, 2009

Last Updated

September 9, 2010

Sponsor

The University of New South Wales

1. Study Identification

Unique Protocol Identification Number

NCT00869765

Brief Title

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

Official Title

An Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) Augmented by D-Cycloserine as a Treatment for Depression.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of New South Wales

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Bipolar Disorder

Keywords

Depression, Treatment, Transcranial direct current stimulation, D-cycloserine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS and D-CYC

Arm Type

Experimental

Arm Description

Major Depression tDCS and D-cyc

Intervention Type

Drug

Intervention Name(s)

D-Cycloserine

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

tDCS (Eldith DC-Stimulator (CE certified))

Other Intervention Name(s)

Eldith DC-Stimulator (CE certified)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Inventory of Depressive Symptomatology (IDS-C)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression). 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). Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen Loo

Organizational Affiliation

University of New South Wales

Official's Role

Principal Investigator

Facility Information:

Facility Name

Black Dog Institute, University of New South Wales

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2032

Country

Australia

12. IPD Sharing Statement

Links:

URL

http://www.blackdoginstitute.org.au

Description

Black Dog Institute website

Learn more about this trial

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

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