Transcranial Direct Current Stimulation (tDCS) Augmentation by D-Cycloserine as a Treatment for Depression
This study has been completed.
Sponsor:
The University of New South Wales
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00869765
First received: March 25, 2009
Last updated: September 9, 2010
Last verified: September 2010
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Inventory of Depressive Symptomatology (IDS-C) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tDCS and D-CYC
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).
Other Name: Eldith DC-Stimulator (CE certified)
|
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
Locations
| Australia, New South Wales | |
| Black Dog Institute, University of New South Wales | |
| 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:
No publications provided
| Responsible Party: | Associate Professor Colleen Loo, University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT00869765 History of Changes |
| Other Study ID Numbers: | 09052 |
| Study First Received: | March 25, 2009 |
| Last Updated: | September 9, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Depressive Disorder, Major Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Cycloserine Anti-Infective Agents, Urinary |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013