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

Sponsored by:	The University of New South Wales
Information provided by:	The University of New South Wales
ClinicalTrials.gov Identifier:	NCT00869765

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder Bipolar Disorder	Drug: D-Cycloserine Device: tDCS (Eldith DC-Stimulator (CE certified))	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	An Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) Augmented by D-Cycloserine as a Treatment for Depression.

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Bipolar Disorder Depression

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
tDCS and D-CYC: Experimental Major Depression tDCS and D-cyc	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).

Arms

Assigned Interventions

tDCS and D-CYC: Experimental

Major Depression tDCS and D-cyc

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).

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869765

Contacts

Contact: Angelo Alonzo, PhD	+61 2 9382 3720	a.alonzo@unsw.edu.au
Contact: Donel Martin, PhD	+61 2 9382 9261	donel.martin@unsw.edu.au

Locations

Australia, New South Wales
Black Dog Institute, University of New South Wales	Recruiting
Randwick, New South Wales, Australia, 2032

Sponsors and Collaborators

The University of New South Wales

Investigators

Principal Investigator:

Colleen Loo

University of New South Wales

More Information

Additional Information:

Black Dog Institute website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of New South Wales ( Associate Professor Colleen Loo )
Study ID Numbers:	09052
Study First Received:	March 25, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00869765 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:

Depression
Treatment
Transcranial direct current stimulation
D-cycloserine

Study placed in the following topic categories:

Antimetabolites
Cycloserine
Anti-Infective Agents
Depression
Bipolar Disorder
Anti-Infective Agents, Urinary
Depressive Disorder, Major
Depressive Disorder

Behavioral Symptoms
Anti-Bacterial Agents
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Psychotic Disorders
Antitubercular Agents

Additional relevant MeSH terms:

Antimetabolites
Cycloserine
Anti-Infective Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Anti-Infective Agents, Urinary
Depressive Disorder, Major
Renal Agents
Depressive Disorder

Pharmacologic Actions
Antibiotics, Antitubercular
Behavioral Symptoms
Anti-Bacterial Agents
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Antitubercular Agents

ClinicalTrials.gov processed this record on September 09, 2009