Major Depressive DisorderPhase 2NCT03937596
Adjunctive D-Cycloserine in Major Depressive Disorder
A Phase 2 study testing D-cycloserine and Transcranial Magnetic Stimulator in people with Major Depressive Disorder, run by University of Calgary at 1 site in Canada.
Trial summary
Transcranial magnetic stimulation (rTMS) is an approved treatment for depression. The purpose of this study is to test an adjunctive medication, D-cycloserine, in rTMS for depression using a placebo-controlled design. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- D-cycloserine and Transcranial Magnetic Stimulator
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2019to 24 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are competent to consent to treatment
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of DSM-5 criteria Major Depressive Disorder with a current episode of at least moderate severity of depression, single or recurrent
- have failed to achieve a clinical response to one adequate trial of antidepressant medication within the current episode, or been unable to tolerate antidepressant medications.
- have a score ≥ 18 on the Hamilton Depression Rating Scale 17-item
- have a Young Mania Rating Scale Score of ≤ 8
- have had no change in dose, or initiation of any psychotropic medication in the 4 weeks prior to randomization
- are able to adhere to the treatment schedule
- pass the TMS adult safety screening (TASS) questionnaire
Who cannot join
- Allergy to Cycloserine
- Have failed adequate trials of ≥4 antidepressant treatments in the current episode.
- have an alcohol or substance use disorder within the last 3 months
- have suicidal ideation (score of 4 ≥ on item 10 of MADRS)
- are at a significant risk of harm to themselves or others
- history of psychosis
Show all 16Show fewer
- are currently pregnant , breast feeding or plan to become pregnant
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of other primary psychiatric diagnoses as assessed by a study investigator to be primary and causing greater impairment than Major Depressive Disorder.
- have failed a course of electroconvulsive therapy (ECT) in the current episode. Previous ECT treatment outside of the current episode does not influence inclusion.
- history of non-response to rTMS treatment.
- 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
- have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
- are currently (or in the last 4 weeks) taking lorazepam or any other benzodiazepine due to the potential to limit rTMS efficacy
- have an exclusion criteria for MRI: Those with a history of cranial, thoracic or abdominal surgery, with pacemakers, artificial joints or other metallic implants will be excluded from the MRI scan. Subjects that have agreed to participate in the MRI portion of the study will be pre-screened for any potential metal fragments in the body (particularly in the orbits) if they have had any history of doing metal work or have been involved in use/deployment of ammunitions/explosives, welding, piping etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-controlled Trial of Adjunctive D-cycloserine in Repetitive Transcranial Magnetic Stimulation for Major Depressive Disorder
Transcranial magnetic stimulation (rTMS) is an approved treatment for depression. The purpose of this study is to test an adjunctive medication, D-cycloserine, in rTMS for depression using a placebo-controlled design. D-Cycloserine is a partial N-Methyl-D-Aspartate receptor (NMDAr) agonist, and therefore may enhance the effects of rTMS, however there is data to support and refute this hypothesis. Using a double-blind design, the investigators will randomize patients with Major Depressive Disorder to receive either daily low dose D-cycloserine or placebo in conjunction with rTMS to the left dorsolateral prefrontal cortex. After 10 treatments (2 weeks), this double-blind period will conclude and all participants will receive an additional 10 treatments (2 weeks) of rTMS without any adjuncts. The primary outcome will be improvement in clinician rated depressive symptoms at the conclusion of the study.
Read the detailed description
Major Depressive Disorder (MDD) is a common and debilitating illness. For an unacceptable proportion of patients, depressive symptoms remain impairing despite multiple treatments. Increasingly, non-invasive brain stimulation techniques are being explored as a means of targeting specific brain regions and networks that are implicated in depression. Repetitive transcranial magnetic stimulation (rTMS) is the non-invasive stimulation technique with the largest evidence base in MDD. Targeting the dorsolateral prefrontal cortex (DLPFC) with rTMS has proven an effective treatment for MDD, however as many as 2/3 of patients will not experience substantial improvement. Adjunctive agents are a potential strategy to improve patient outcomes.
The objective of the proposed study is to determine the efficacy of adjunctive D-cycloserine with rTMS directed to the left dorsolateral prefrontal cortex (DLPFC) in acute Major Depressive Episodes. The investigators propose to utilize a stimulation protocol called the intermittent theta-burst protocol to study rTMS in conjunction with D-cyloserine using a randomized double-blind, placebo-controlled design with allocation concealment. Patients with Major Depressive Disorder will be randomized to receive 1) rTMS+cycloserine, or 2) rTMS+placebo in a 1:1 ratio for two weeks (10 sessions).
At the conclusion of the 2-week blinded augmentation phase, patients will continue to receive two weeks of rTMS without an augmentation agent or placebo.
The primary outcome measures will be improvement in depression as measured by change in Montgomery Asberg Depression Rating Scale (MADRS). In addition, the investigators will also be looking at the improvement of other clinical outcome measures, quality of life and changes in brain functional dynamics, as assessed with functional Magnetic Resonance Imaging (MRI), and metabolites, as assessed by Magnetic Resonance (MR) Spectroscopy.
- Conditions
- Major Depressive Disorder
- Being tested
- D-cycloserine, Transcranial Magnetic Stimulator, Placebo oral capsule
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called Seromycin
Daily oral D-cycloserine 100mg during the blinded phase (10 days).
Transcranial Magnetic StimulatorDevice
Repetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks.
Placebo oral capsuleDrug
Daily oral placebo during the blinded phase (10 days).
| Study group | Role | What they receive |
|---|---|---|
| D-Cycloserine | Experimental | Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine daily (Monday-Friday) for the first 2 weeks of rTMS treatment (10 sessions), followed by 2 weeks of rTMS without adjunctive medication. Receives: Drug: D-cycloserine; Device: Transcranial Magnetic Stimulator |
| Placebo | Placebo comparator | 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 the first 2 weeks of rTMS treatment (10 sessions), followed by 2 weeks of rTMS without adjunctive medication. Receives: Device: Transcranial Magnetic Stimulator; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Change in severity of depressive symptoms as measured by the MADRS, a clinician-rated instrument. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. The overall score ranges from 0 - 60. Cutoff points are 0-6 = normal, 7-9 = mild depression, 20-34 = moderate depression, >34 = severe depression.
Measured: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Secondary outcomes (18)
Functional Magnetic Resonance Imaging (fMRI)
Change in task and resting state functional connectivity as determined by an fMRI.
Measured: Administered at baseline and week 2. Change in cycloserine group vs change in placebo group
Magnetic Resonance (MR) spectroscopy
Change in brain metabolites in regions of interest.
Measured: Administered at baseline and week 2. Change in cycloserine group vs change in placebo group
Clinical Remission
Score of </= 10 on the MADRS
Measured: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Clinical Response
>/= 50% reduction in MADRS scores
Measured: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Quality of Life as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
The WHOQOL-BREF is a self-reported questionnaire which assesses individual's perception of their quality of life across 4 domains; physical health, psychological, social relationships and environment. Domains scores are calculated to range from 0-20 and scaled in a positive direction (ie. higher scores denote higher quality of life).
Measured: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Anxiety Symptoms
Anxiety symptoms will be assessed using the 7 item Generalized Anxiety Disorder (GAD-7) questionnaire. The GAD-7 measures self-reported feelings of anxiety within the last 2 weeks. Scores range from 0-21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.
Measured: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Workplace Productivity
Productivity will be assessed using the Lam Employment Absence and Disability Scale (LEAPS). The LEAPS is a 10-item, self-rated scale and provides information on how participants are functioning at work. Scores range from 0 - 28, with higher scores representing more severe work impairment.
Measured: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Functional Disability
Functional disability will be assessed using the Sheehan Disability Scale (SDS). The SDS is a self-report scale to assess functional impairment in three domains; work/school, social and family life. Scores range from 0 - 30, with higher scores representing greater impairment.
Measured: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Clinical Global Impression
Clinical Global Impression will be assessed using the Clinical Global Impression (CGI) Severity and Improvement scales. The CGI-Severity scale is clinician rated from 1-7 representing 'Not at all ill' to 'Severely ill'. The CGI-Improvement scale is also rated 1-7, representing the range between 'Very much improved' and 'Very much worse'.
Measured: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Cognitive Function
Cognitive function will be assessed using the THINC-it brief cognitive assessment tool. THINC-it includes 4 objective cognitive tests (adapted from choice reaction time, 1-back working memory task, symbol digit coding, and Trails-B) and a subjective cognitive questionnaire (PDQ-5). Results indicate cognitive performance compared to healthy age-, sex- and education-matched individuals.
Measured: Administered at baseline and at the halfway point (week 2)
Implicit Suicidal Thoughts
Death Implicit Association Test (D-IAT) is a behavioral test that measures the strength of automatic (implicit) associations between concepts in people's minds relying on latency measures in a simple sorting task. The strength of an association between concepts of "death" and "ones self" is measured by the standardized mean difference score of the 'hypothesis-inconsistent' pairings and 'hypothesis-consistent' pairings
Measured: Administered at baseline and at the halfway point (week 2)
Personality Measures- BFI
The Big Five Inventory (BFI) is a self-report inventory designed to measure the Big Five dimensions of personality: extroversion, agreeableness, openness, conscientiousness, and neuroticism. The test consists of 44 items that you must rate on how true they are about you on a five point scale where 1=Disagree, 3=Neutral and 5=Agree.
Measured: Administered at baseline and after rTMS treatment (week 4)
Personality Measures- DEQ
The Depressive Experiences Questionnaire (DEQ) is a 66 item questionnaire where participants rate themselves on life experiences and personality characteristics frequently associated with depression. Participants are asked to rate each item on a seven-point Likert-type scale ranging from strongly disagree (1) to strongly agree (7). Analysis of results produces 3 factors: Dependency, Self-criticism, and Efficacy.
Measured: Administered at baseline and after rTMS treatment (week 4)
Anhedonia
The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self report developed to measure ability to experience pleasure (hedonic tone) and its absence (anhedonia) in the last few days. Each item asks participants to agree or disagree with how pleasurable a certain scenario would be. Disagree responses receive a score of 1 and Agree responses receive a score of 0. The SHAPS is scored as the sum of the 14 items so that total scores ranged from 0 to 14. A higher total SHAPS score indicated higher levels of anhedonia.
Measured: Administered at baseline and after rTMS treatment (week 4)
Self-reported Cognition
The Cognitive Failures Questionnaire (CFQ) measures self-reported failures in perception, memory, and motor function in the completion of everyday tasks. Individuals are asked to rate the frequency experiences and behaviors on a 5-point scale: 0-Never, 1-Very rarely, 2-Occasionally, 3-Quite often, 4-Very often.
Measured: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Depressive Symptoms
The Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) is a scale of self-report measure of depression. Questions in the QIDS - SRcorrelate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance, Sad mood, Decrease/increase in appetite/weight, Concentration, Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation.Severity of depression can be judged based on the total score.
1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression
Measured: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
VAS for General Health
A Visual Analog Scale (VAS) will ask participants how good or bad their health is today. This scale is numbered from 0 to 100. 100 indicates the best health they can imagine. 0 indicates the worst health they can imagine.
Measured: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Perception of Illness
The Brief Illness Perception Questionnaire (BIPQ) is a nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. The BIPQ assesses perception on a 0 (minimum) -10 (maximum) response scale. It includes 5 items on cognitive representation of illness perception, 2 items on emotional representation, 1 item on illness comprehensibility, and 1 item on perceived cause of illness.
Measured: Administered at baseline and after rTMS treatment (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Dec 2019
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander McGirr, MD PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937596
- Sponsor's protocol ID
- REB18-2142
- Status last verified
- Dec 2021
- First submitted
- 29 Apr 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cole J, Sohn MN, Harris AD, Bray SL, Patten SB, McGirr A. Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Dec 1;79(12):1153-1161. doi: 10.1001/jamapsychiatry.2022.3255.
PubMed 36223114
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Trial of Adjunctive D-cycloserine in Repetitive Transcranial Magnetic Stimulation for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03937596
- Acronym / sponsor ID
- REB18-2142
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial magnetic stimulation (rTMS) is an approved treatment for depression. The purpose of this study is to test an adjunctive medication, D-cycloserine, in rTMS for depression using a placebo-controlled design. D-Cycloserine is a partial N-Methyl-D-Aspartate receptor (NMDAr) agonist, and therefore may enhance the effects of rTMS, however there is data to support and refute this hypothesis. Using a double-blind design, the investigators will randomize patients with Major Depressive Disorder to receive either daily low dose D-cycloserine or placebo in conjunction with rTMS to the left dorsolateral prefrontal cortex. After 10 treatments (2 weeks), this double-blind period will conclude and all participants will receive an additional 10 treatments (2 weeks) of rTMS without any adjuncts. The primary outcome will be improvement in clinician rated depressive symptoms at the conclusion of the study.
Detailed description
Major Depressive Disorder (MDD) is a common and debilitating illness. For an unacceptable proportion of patients, depressive symptoms remain impairing despite multiple treatments. Increasingly, non-invasive brain stimulation techniques are being explored as a means of targeting specific brain regions and networks that are implicated in depression. Repetitive transcranial magnetic stimulation (rTMS) is the non-invasive stimulation technique with the largest evidence base in MDD. Targeting the dorsolateral prefrontal cortex (DLPFC) with rTMS has proven an effective treatment for MDD, however as many as 2/3 of patients will not experience substantial improvement. Adjunctive agents are a potential strategy to improve patient outcomes.
The objective of the proposed study is to determine the efficacy of adjunctive D-cycloserine with rTMS directed to the left dorsolateral prefrontal cortex (DLPFC) in acute Major Depressive Episodes. The investigators propose to utilize a stimulation protocol called the intermittent theta-burst protocol to study rTMS in conjunction with D-cyloserine using a randomized double-blind, placebo-controlled design with allocation concealment. Patients with Major Depressive Disorder will be randomized to receive 1) rTMS+cycloserine, or 2) rTMS+placebo in a 1:1 ratio for two weeks (10 sessions).
At the conclusion of the 2-week blinded augmentation phase, patients will continue to receive two weeks of rTMS without an augmentation agent or placebo.
The primary outcome measures will be improvement in depression as measured by change in Montgomery Asberg Depression Rating Scale (MADRS). In addition, the investigators will also be looking at the improvement of other clinical outcome measures, quality of life and changes in brain functional dynamics, as assessed with functional Magnetic Resonance Imaging (MRI), and metabolites, as assessed by Magnetic Resonance (MR) Spectroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Cycloserine | Experimental | Drug: D-cycloserine, Device: Transcranial Magnetic StimulatorParticipants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine daily (Monday-Friday) for the first 2 weeks of rTMS treatment (10 sessions), followed by 2 weeks of rTMS without adjunctive medication. |
| Placebo | Placebo comparator | Device: Transcranial Magnetic Stimulator, Drug: Placebo oral capsuleParticipants 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 the first 2 weeks of rTMS treatment (10 sessions), followed by 2 weeks of rTMS without adjunctive medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are competent to consent to treatment
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of DSM-5 criteria Major Depressive Disorder with a current episode of at least moderate severity of depression, single or recurrent
- have failed to achieve a clinical response to one adequate trial of antidepressant medication within the current episode, or been unable to tolerate antidepressant medications.
- have a score ≥ 18 on the Hamilton Depression Rating Scale 17-item
- have a Young Mania Rating Scale Score of ≤ 8
Key exclusion criteria (16 listed)
- Allergy to Cycloserine
- Have failed adequate trials of ≥4 antidepressant treatments in the current episode.
- have an alcohol or substance use disorder within the last 3 months
- have suicidal ideation (score of 4 ≥ on item 10 of MADRS)
- are at a significant risk of harm to themselves or others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserineAlso: SeromycinDaily oral D-cycloserine 100mg during the blinded phase (10 days). | Drug | D-Cycloserine |
| Transcranial Magnetic StimulatorRepetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks. | Device | D-Cycloserine, Placebo |
| Placebo oral capsuleDaily oral placebo during the blinded phase (10 days). | Drug | Placebo |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Change in severity of depressive symptoms as measured by the MADRS, a clinician-rated instrument. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. The overall score ranges from 0 - 60. Cutoff points are 0-6 = normal, 7-9 = mild depression, 20-34 = moderate depression, >34 = severe depression.
18 secondary outcomes
Functional Magnetic Resonance Imaging (fMRI)
Time frame: Administered at baseline and week 2. Change in cycloserine group vs change in placebo group
Magnetic Resonance (MR) spectroscopy
Time frame: Administered at baseline and week 2. Change in cycloserine group vs change in placebo group
Clinical Remission
Time frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Clinical Response
Time frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Quality of Life as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
Time frame: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Anxiety Symptoms
Time frame: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Workplace Productivity
Time frame: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Functional Disability
Time frame: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Clinical Global Impression
Time frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Cognitive Function
Time frame: Administered at baseline and at the halfway point (week 2)
Implicit Suicidal Thoughts
Time frame: Administered at baseline and at the halfway point (week 2)
Personality Measures- BFI
Time frame: Administered at baseline and after rTMS treatment (week 4)
Personality Measures- DEQ
Time frame: Administered at baseline and after rTMS treatment (week 4)
Anhedonia
Time frame: Administered at baseline and after rTMS treatment (week 4)
Self-reported Cognition
Time frame: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
Depressive Symptoms
Time frame: Administered at baseline, week 1, at the halfway point (week 2), week 3, and after rTMS treatment (week 4)
VAS for General Health
Time frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Perception of Illness
Time frame: Administered at baseline and after rTMS treatment (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 36223114Cole J, Sohn MN, Harris AD, Bray SL, Patten SB, McGirr A. Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Dec 1;79(12):1153-1161. doi: 10.1001/jamapsychiatry.2022.3255.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander McGirr, MD PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-cycloserine and Transcranial Magnetic Stimulator in people with Major Depressive Disorder, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.