What side effects are associated with this type of intervention?

Common treatments for OCD include SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine), and antipsychotics (e.g., risperidone). SSRIs and SNRIs can cause side effects such as nausea, headache, insomnia, sexual dysfunction, and weight gain. Antipsychotics may lead to weight gain, sedation, and metabolic changes. D-Cycloserine, used as an adjunct to brain stimulation, has limited evidence of efficacy and its side effects are not well-documented but may include dizziness and headache. Cognitive-behavioral therapy (CBT) is also a common treatment and is generally well-tolerated with minimal side effects.

What prior FDA approvals exist?

The FDA has approved transcranial magnetic stimulation (TMS) for the treatment of Obsessive-Compulsive Disorder (OCD) in August 2018. This approval is significant as it relates to the ongoing study of D-Cycloserine (DCS) used in conjunction with TMS to enhance synaptic plasticity. Additionally, serotonergic reuptake inhibitors (SRIs) such as fluoxetine, fluvoxamine, and clomipramine, as well as antipsychotic agents like quetiapine, have been commonly used in the treatment of OCD. These treatments aim to manage symptoms by altering neurotransmitter activity in the brain.

What other types of research exist?

Promising novel alternatives to D-Cyloserine for OCD treatment in 2024 include: 1) Deep Brain Stimulation (DBS) targeting the nucleus accumbens or the Bed Nucleus of Stria Terminalis (BNST), which has shown efficacy in treatment-refractory OCD with minimal cognitive side effects. 2) Non-invasive brain stimulation techniques such as repetitive Transcranial Magnetic Stimulation (rTMS), which has demonstrated moderate effectiveness in reducing OCD symptoms. These alternatives offer new avenues for patients who have not responded to traditional treatments.

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Behavioural Intervention

D-Cycloserine + TMS for Obsessive-Compulsive Disorder

Phase 2

Waitlist Available

Led By Alexander McGirr, MD, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have failed to achieve a clinical response to one adequate trial of serotonin reuptake inhibitor or cognitive behavioral therapy with an adequate trial of 2 months medication within the current episode, or been unable to tolerate antidepressant medications

Males and females aged 18 to 65 years

Must not have

Have failed a course of ECT in the current episode. Previous ECT treatment outside of the current episode does not influence inclusion

Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space-occupying brain lesion, any history of epilepsy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

Summary

This trial will help determine if D-Cyloserine, when used alongside transcranial magnetic stimulation, is an effective treatment for Obsessive Compulsive Disorder.

Who is the study for?

Adults aged 18-65 with a confirmed diagnosis of Obsessive Compulsive Disorder (OCD) who haven't responded to certain treatments and have a score ≥ 20 on the YBOCS. Participants must not have changed psychotropic medications in the last 8 weeks, be able to consent, adhere to treatment schedules, and pass TMS safety screenings. Exclusions include allergy to cycloserine, recent substance abuse, suicidal ideation, psychosis history, pregnancy or breastfeeding women, unstable medical conditions or metal implants near the head.

What is being tested?

The trial is testing if D-cycloserine (DCS), when taken with repetitive Transcranial Magnetic Stimulation (rTMS), can improve OCD symptoms compared to placebo. It's randomized: participants will either get real rTMS with DCS or sham rTMS with a placebo capsule without knowing which one they're getting.

What are the potential side effects?

Possible side effects may include discomfort at stimulation site from rTMS; headache; dizziness; scalp tingling during rTMS sessions; seizures are rare but possible. For D-cycloserine: allergic reactions like rash or fever; mood changes such as anxiety or confusion might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I tried an antidepressant or therapy for 2 months without improvement or couldn't tolerate the medication.

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I am between 18 and 65 years old.

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I haven't changed or started any mental health medication in the last 8 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tried ECT for my current health issue without success.

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I do not have major brain or nerve conditions like epilepsy, Parkinson's, or severe head injuries.

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I do not have a serious unstable illness, pacemaker, or medication pump.

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I am experiencing symptoms of psychosis.

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I did not respond to previous rTMS treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at the halfway point (week 2), after rtms treatment (week 4), and at one month follow up (week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Yale-Brown Obsessive Compulsive Scale (YBOCs)

Secondary study objectives

Change in Cognitive Function - THINC-it- Choice Reaction Time

Change in Cognitive Function - THINC-it- Digit Symbol Substitution

Change in Cognitive Function - THINC-it- PDQ-5

+20 more

Other study objectives

Incidence of Treatment-Emergent Adverse Events

Side Effects

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: TMS+DCSActive Control2 Interventions

The Transcranial Magnetic Stimulation (TMS) involves magnetic stimulation of the brain to the left medial prefrontal cortex (mPFC) daily for four weeks. The stimulation is intermittent Theta-Burst (iTBS). Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine (DCS) daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.

Group II: TMS+PlaceboActive Control2 Interventions

The Transcranial Magnetic Stimulation (TMS) involves magnetic stimulation of the brain to the left medial prefrontal cortex (mPFC) daily for four weeks. The stimulation is intermittent Theta-Burst (iTBS). Participants will orally ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.

Group III: shamTMS+DCSPlacebo Group2 Interventions

Sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered to the brain. Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine (DCS) daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.

Group IV: shamTMS+placeboPlacebo Group2 Interventions

Sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered to the brain. Participants will orally ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) one hour prior to rTMS treatment.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs), cognitive-behavioral therapy (CBT) with exposure and response prevention (ERP), and, more recently, neuromodulation techniques like transcranial magnetic stimulation (TMS). SSRIs work by increasing serotonin levels in the brain, which helps regulate mood and anxiety. CBT with ERP focuses on reducing the compulsive behaviors by gradually exposing patients to their fears and preventing the associated compulsive actions. D-Cycloserine (DCS) is an adjunctive medication that enhances synaptic plasticity, making the brain more receptive to the therapeutic effects of TMS and CBT. This is particularly important for OCD patients as it can potentially accelerate and enhance treatment outcomes, offering hope for those who are resistant to conventional therapies.

The Emergence of a Stereotypic Movement During Intensive Short-Term Dynamic Psychotherapy in a Patient with Obsessive Compulsive Disorder: A Case Report.