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

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder, Bipolar Disorder

Intervention / Treatment
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* Drug: D-Cycloserine
* Device: tDCS (Eldith DC-Stimulator (CE certified))


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS and D-CYC<br>Major Depression tDCS and D-cyc | Drug: D-Cycloserine<br>* 100 mg D-cycloserine once every weekday taken 2 hours before tDCS session.<br>Device: tDCS (Eldith DC-Stimulator (CE certified))<br>* 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).<br>* Other names: Eldith DC-Stimulator (CE certified);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Depressive Symptomatology (IDS-C) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Treatment, Transcranial direct current stimulation, D-cycloserine