Cancer in Remission (Any Type or Stage)rTMSinCPNCT01701284

Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cancer in Remission (Any Type or Stage) and Depression, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 80 years
Conditions the study is for: Cancer in Remission (Any Type or Stage), Depression, Anxiety
What is being tested?: Repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Dec 2012to May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Adults aged 22-80; 2. Have a previous diagnosis of cancer (any type or stage) as confirmed by official medical records; 3. Have a Diagnostic and Statistical Manual (DSM-IV) diagnosis of Major Depressive Disorder; 4. Have a Hamilton Depression Rating (HAM-D) 24-item score of more than 20; 5. Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode; 6. All participants must have given signed, informed consent prior to registration in study.

Who cannot join

1. Participant with any type of brain tumor; 2. Participant with cancer with brain metastases; 3. Evidence of the disease at the time of entry into the trial; 4. Presence or recent history of other concurrent cancers, with the following exceptions: a. Participants with completely treated basal or squamous skin cancers could be included in the study if their physicians deem that they are medically stable, b. Participants with completely treated in situ carcinoma of the breast or cervix could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable, c. Participants with pre-cancerous lesions in the colon could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable; 5. Participant had recent surgery within two weeks of screening; 6. Participants undergoing chemotherapy; 7. Participant pregnant or nursing; 8. Participant with any metallic object in or around their head; 9. Participant with a pacemaker; 10. Participants with unstable suicidal ideation as determined by the patient's treating psychiatrist; 11. Participants with a substance use disorder within the prior six months; 12. Significant history of head injury/trauma as defined by loss of consciousness for more than one hour; 13. Recurring seizures resulting from the head injury; 14. Clear cognitive sequelae from the head injury and cognitive rehabilitation following the injury; 15. Any disorder that would predispose the participant to seizures; 16. Use of concomitant medications that substantially increase seizure risk.; Such drugs could include neuroleptics (ex. haloperidol, droperidol), clozapine, tricyclic antidepressants (ex. amoxapine, clomipramine), bupropion (particularly the immediate release (IR) formulation), donepezil, psychostimulants (ex. methylphenidate), theophylline and/or other drugs that reduce the seizure threshold. For individuals on any of these medicines, a study clinician evaluated the drugs and doses to determine the risks and benefits. These were then discussed with the individual's Primary Care Physician to determine if the individual could be included in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Randomized Open-Label Pilot Trial To Evaluate The Safety And Efficacy Of Repetitive Transcranial Magnetic Stimulation In Cancer Patients With Depression And Anxiety

Cancer is a leading cause of mortality and morbidity worldwide. In addition, cancer is associated with high rates of depression and anxiety among its sufferers, and cancer patients with depression usually have worse treatment outcomes and long-term survival. Surprisingly, many cancer patients with depression do not receive treatment for their depression, perhaps because treatments for cancer-related depression are usually adapted from those used in non-cancer populations and may not be suitable for cancer patients. Moreover, cancer patients with depression are more likely to have a long latency of anti-depressant drug action, negative drug-drug interactions with cancer chemotherapies and an increased susceptibility for systemic side effects. Repetitive transcranial magnetic stimulation (rTMS) is a new treatment modality for depression that affects the brain directly with no systemic side effects and poses no potential for drug-drug interactions. rTMS therapy was recently cleared by the FDA as an antidepressant treatment for treatment-resistant Major Depressive Disorder, and now is being evaluated for a wide array of additional psychiatric indications. This randomized, open label, two-arm, pilot study will investigate the safety, tolerability, feasibility and the efficacy of two forms of rTMS (i.e., left (fast) and right (slow) sided rTMS) in cancer-related depression. The study hypotheses are that rTMS will significantly reduce symptoms of depression and that right-sided slow rTMS will be more effective than left-sided fast rTMS for the treatment of severe anxiety.

Conditions: Cancer in Remission (Any Type or Stage), Depression, Anxiety
Being tested: Repetitive Transcranial Magnetic Stimulation (rTMS)
Keywords: repetitive Transcranial Magnetic Stimulation, Cancer Survivors, Depression, Anxiety
Medical subject headings: Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called Neurostar TMS Therapy(R) System

Study groups in NCT01701284
Study group	Role	What they receive
Right-Sided Low-Frequency rTMS	Experimental	Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Left-Sided High-Frequency rTMS	Experimental	Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
This measure reports the overall change in depression severity(HDRS-17) from baseline (Week 0) at each follow-up assessment. Overall Change is defined as the score at each subsequent time point minus the score at Baseline.
Scale Information:
Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity.
Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items.
Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome.
Calculation Logic:
The values reported are the absolute difference of outcomes for each treatment arm. For each participant, the relative change is calculated as: Score at Visit - Baseline Score. Negative numbers indicates a reduction in symptom severity (improvement) and a positive number indicates worsening in symptom severity
Measured: Baseline (Week 0), Week 2, Week 4 and Week 6.
Relative Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
Measure Description:
This measure reports the relative (percentage) change in depression severity from baseline (Week 0) at each follow-up assessment.
Scale Information:
Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity.
Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items.
Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome.
Calculation Logic:
The values reported are the mean percentage changes for each treatment arm. For each participant, the relative change is calculated as: ((Score at Visit - Baseline Score) / Baseline Score) * 100. A negative percentage indicates a reduction in symptom severity (improvement).
Measured: Baseline (Week 0), Week 2, Week 4 and Week 6
Number of Participants With Treatment-Emergent Side Effects (UKU)
Side effects assessed at Weeks 2, 4, 6 via Udvalg for Kliniske Undersøgelser (UKU) scale (48 items, 0=none to 3=severe; higher=worse). 'Treatment-emergent' worsening is a score increase ≥1 from baseline (Tx #1) on any item with possible/probable relation to intervention. Data reported is the count of participants meeting criteria for any of the clusters.
Psychic Cluster: concentration, asthenia, sedation, memory, depression, unrest, sleep/dream changes, emotional indifference.
Neurological Cluster: dystonia, rigidity, hypokinesia, hyperkinesia, tremor, akathisia, seizures, paresthesia, headache.
Autonomic Cluster: accommodation, salivation, nausea/vomiting, diarrhea, constipation, micturition, polyuria, dizziness, tachycardia, sweating.
Other Cluster: rash, pruritus, photosensitivity, weight change, menses changes, galactorrhea, gynecomastia, libido changes, erectile dysfunction.
Measured: Baseline (Week 0), Week 2, Week 4, and Week 6

Secondary outcomes (4)

Overall Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6
Measure Description:
The overall change in anxiety severity is assessed using the total score of the Hamilton Anxiety Rating Scale (HAM-A) at each protocol-specified follow-up visit compared to the baseline score at baseline(Week 0) Scale Information: Hamilton Anxiety Rating Scale (HAM-A) Construct: A clinician-rated scale used to measure the severity of a patient's anxiety symptoms, including both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints).
Total Score Calculation: The total score is calculated by summing the individual scores of all 14 items.
Range: Total scores range from 0 to 56. Directionality: Higher values represent a worse outcome (greater anxiety severity), while lower values represent a better outcome.
Calculation Logic:
The values reported represent the absolute difference in scores for each treatment arm at every assessment interval minus the score at baseline.
Measured: Baseline (Week 0), Week 1- Week 6 (Weekly assessments)
Relative Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6
This measure reports the relative (percentage) change in anxiety severity from baseline (Week 0) at each follow-up assessment.
Scale name: Hamilton Anxiety Rating Scale (HAM-A). It is a clinician-rated scale used to measure the severity of a patient's anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, measuring both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe). Total score is calculated by summing all 14 items. The total Score ranges from 0 to 56. Higher values represent a worse outcome (greater severity of anxiety), while lower values represent a better outcome. For each protocol-specified time point (Weeks 1-6), the relative change is calculated for as: ((Score at Visit - Baseline Score(Week 0) /Baseline Score)*100. A negative percentage indicates a reduction in symptoms (better outcome).
Measured: Baseline(Week 0), Week 1- Week 6 (Weekly assessments)
Correlation Between Baseline Anxiety (HAM-A) and Change in Depression Severity (HDRS-17, HAM-D)
This measure assesses the relationship between the severity of anxiety symptoms at the start of treatment and the magnitude of depression improvement at Week 6.
Scale 1: Hamilton Anxiety Rating Scale (HAM-A). Measures anxiety severity. Total range: 0 to 56. Higher values = worse outcome.
Scale 2: Hamilton Depression Rating Scale (HDRS-17, HAM-D). Measures depression severity. Total range: 0 to 50. Higher values = worse outcome.
Statistical Analysis \& Interpretation:
Change Calculation: Depression change is calculated as (Week 6 Score - Baseline Score). A more negative value represents greater improvement.
Coefficient: Spearman's rank correlation coefficient (rho) is used. Interpretation: A positive correlation indicates that higher baseline anxiety is associated with higher (less negative) change scores, meaning less improvement. A negative correlation indicates that higher baseline anxiety is associated with lower (more negative) change scores, meaning greater improvement.
Measured: Baseline (Week 0) and Week 6
Correlation Between Baseline Anxiety (HAM-A) and Harm Avoidance (TCI-R)
This measure assesses the relationship between clinical anxiety symptoms and the personality trait of Harm Avoidance at baseline.
Scale Information:
Scale 1: Hamilton Anxiety Rating Scale (HAM-A). Measures anxiety severity. Total range: 0 to 56. Higher values = worse outcome.
Scale 2: Temperament and Character Inventory-Revised (TCI-R) - Harm Avoidance Subscale. Measures the personality trait of Harm Avoidance. Results are reported as standardized T-scores (mean of 50, standard deviation of 10). The typical range for T-scores is 20 to 80.
Outcome Direction: For both scales, higher values represent higher levels of the construct (more anxiety and higher harm avoidance).
Statistical Analysis \& Interpretation:
Coefficient: Spearman's rank correlation coefficient (rho). Interpretation: A positive correlation indicates that individuals with higher clinical anxiety symptoms also tend to score higher on the personality trait of Harm Avoidance.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012May 2023

First posted5 Oct 2012 (estimated)
Study startDec 2012
Primary completionMay 2023
Study completionMay 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Cancer in Remission (Any Type or Stage)Studies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01701284
Sponsor's protocol ID: NU 12CC12
Other IDs: NCI-2012-01691
Acronym: rTMSinCP
Status last verified: May 2026
First submitted: 3 Oct 2012
Last updated: 24 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.
PubMed 15695497
George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
PubMed 20439832
Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.
PubMed 18232722
Machado S, Paes F, Velasques B, Teixeira S, Piedade R, Ribeiro P, Nardi AE, Arias-Carrion O. Is rTMS an effective therapeutic strategy that can be used to treat anxiety disorders? Neuropharmacology. 2012 Jan;62(1):125-34. doi: 10.1016/j.neuropharm.2011.07.024. Epub 2011 Jul 27.
PubMed 21807002
O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
PubMed 17573044
Paes F, Machado S, Arias-Carrion O, Velasques B, Teixeira S, Budde H, Cagy M, Piedade R, Ribeiro P, Huston JP, Sack AT, Nardi AE. The value of repetitive transcranial magnetic stimulation (rTMS) for the treatment of anxiety disorders: an integrative review. CNS Neurol Disord Drug Targets. 2011 Aug;10(5):610-20. doi: 10.2174/187152711796234943.
PubMed 21631403
Schutter DJ. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med. 2009 Jan;39(1):65-75. doi: 10.1017/S0033291708003462. Epub 2008 Apr 30.
PubMed 18447962
Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. doi: 10.4088/JCP.08m04872gre. Epub 2010 Mar 9.
PubMed 20361902

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Open-Label Pilot Trial To Evaluate The Safety And Efficacy Of Repetitive Transcranial Magnetic Stimulation In Cancer Patients With Depression And Anxiety
ClinicalTrials.gov ID: NCT01701284
Acronym / sponsor ID: rTMSinCP / NU 12CC12
Conditions: Cancer in Remission (Any Type or Stage), Depression, Anxiety
Keywords: repetitive Transcranial Magnetic Stimulation, Cancer Survivors, Depression, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Neuronetics
Study start: Dec 2012
Primary completion: May 2023 (actual)
Study completion: May 2023 (actual)
First posted: 5 Oct 2012 (estimated)
Results: Posted 24 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Right-Sided Low-Frequency rTMS	Experimental	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will have rTMS administered at 1Hz to the right dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks.
Left-Sided High-Frequency rTMS	Experimental	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants will have rTMS administered at 10Hz to the left dorsolateral Prefrontal Cortex (dlPFC) once a day for 40 minutes, 5 days a week, for a total of six weeks.

Who may qualify

Ages: 22 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Adults aged 22-80; 2. Have a previous diagnosis of cancer (any type or stage) as confirmed by official medical records; 3. Have a Diagnostic and Statistical Manual (DSM-IV) diagnosis of Major Depressive Disorder; 4. Have a Hamilton Depression Rating (HAM-D) 24-item score of more than 20; 5. Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode; 6. All participants must have given signed, informed consent prior to registration in study.

Key exclusion criteria (1 listed)

1. Participant with any type of brain tumor; 2. Participant with cancer with brain metastases; 3. Evidence of the disease at the time of entry into the trial; 4. Presence or recent history of other concurrent cancers, with the following exceptions: a. Participants with completely treated basal or squamous skin cancers could be included in the study if their physicians deem that they are medically stable, b. Participants with completely treated in situ carcinoma of the breast or cervix could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable, c. Participants with pre-cancerous lesions in the colon could be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable; 5. Participant had recent surgery within two weeks of screening; 6. Participants undergoing chemotherapy; 7. Participant pregnant or nursing; 8. Participant with any metallic object in or around their head; 9. Participant with a pacemaker; 10. Participants with unstable suicidal ideation as determined by the patient's treating psychiatrist; 11. Participants with a substance use disorder within the prior six months; 12. Significant history of head injury/trauma as defined by loss of consciousness for more than one hour; 13. Recurring seizures resulting from the head injury; 14. Clear cognitive sequelae from the head injury and cognitive rehabilitation following the injury; 15. Any disorder that would predispose the participant to seizures; 16. Use of concomitant medications that substantially increase seizure risk.; Such drugs could include neuroleptics (ex. haloperidol, droperidol), clozapine, tricyclic antidepressants (ex. amoxapine, clomipramine), bupropion (particularly the immediate release (IR) formulation), donepezil, psychostimulants (ex. methylphenidate), theophylline and/or other drugs that reduce the seizure threshold. For individuals on any of these medicines, a study clinician evaluated the drugs and doses to determine the risks and benefits. These were then discussed with the individual's Primary Care Physician to determine if the individual could be included in the study.

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
Repetitive Transcranial Magnetic Stimulation (rTMS)Also: Neurostar TMS Therapy(R) System	Device	Left-Sided High-Frequency rTMS, Right-Sided Low-Frequency rTMS

Primary outcome

Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
Time frame: Baseline (Week 0), Week 2, Week 4 and Week 6.
This measure reports the overall change in depression severity(HDRS-17) from baseline (Week 0) at each follow-up assessment. Overall Change is defined as the score at each subsequent time point minus the score at Baseline. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the absolute difference of outcomes for each treatment arm. For each participant, the relative change is calculated as: Score at Visit - Baseline Score. Negative numbers indicates a reduction in symptom severity (improvement) and a positive number indicates worsening in symptom severity
Relative Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6
Time frame: Baseline (Week 0), Week 2, Week 4 and Week 6
Measure Description: This measure reports the relative (percentage) change in depression severity from baseline (Week 0) at each follow-up assessment. Scale Information: Name: Hamilton Depression Rating Scale (HDRS-17). Construct: The HDRS-17 is a clinician-administered assessment of depressive symptom severity. Total Score Calculation: The total score is calculated by summing the individual scores of all 17 items. Range: Total scores range from 0 to 52. Directionality: Higher values represent a worse outcome (more severe depression), while lower values represent a better outcome. Calculation Logic: The values reported are the mean percentage changes for each treatment arm. For each participant, the relative change is calculated as: ((Score at Visit - Baseline Score) / Baseline Score) * 100. A negative percentage indicates a reduction in symptom severity (improvement).
Number of Participants With Treatment-Emergent Side Effects (UKU)
Time frame: Baseline (Week 0), Week 2, Week 4, and Week 6
Side effects assessed at Weeks 2, 4, 6 via Udvalg for Kliniske Undersøgelser (UKU) scale (48 items, 0=none to 3=severe; higher=worse). 'Treatment-emergent' worsening is a score increase ≥1 from baseline (Tx #1) on any item with possible/probable relation to intervention. Data reported is the count of participants meeting criteria for any of the clusters. Psychic Cluster: concentration, asthenia, sedation, memory, depression, unrest, sleep/dream changes, emotional indifference. Neurological Cluster: dystonia, rigidity, hypokinesia, hyperkinesia, tremor, akathisia, seizures, paresthesia, headache. Autonomic Cluster: accommodation, salivation, nausea/vomiting, diarrhea, constipation, micturition, polyuria, dizziness, tachycardia, sweating. Other Cluster: rash, pruritus, photosensitivity, weight change, menses changes, galactorrhea, gynecomastia, libido changes, erectile dysfunction.

4 secondary outcomes

Overall Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6
Time frame: Baseline (Week 0), Week 1- Week 6 (Weekly assessments)
Relative Change in Anxiety Severity (HAM-A) at Weeks 1, 2, 3, 4, 5, and 6
Time frame: Baseline(Week 0), Week 1- Week 6 (Weekly assessments)
Correlation Between Baseline Anxiety (HAM-A) and Change in Depression Severity (HDRS-17, HAM-D)
Time frame: Baseline (Week 0) and Week 6
Correlation Between Baseline Anxiety (HAM-A) and Harm Avoidance (TCI-R)
Time frame: Baseline

Results and safety

Results posted to the registry on 24 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Right-Sided Low-Frequency rTMS	13	12
Left-Sided High-Frequency rTMS	11	8

Primary outcome: Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6

Time frame: Baseline (Week 0), Week 2, Week 4 and Week 6.. Mean (Standard Deviation). Unit: Score change from baseline

Measure	Right-Sided Low-Frequency rTMS n = 12	Left-Sided High-Frequency rTMS n = 8
Week 2 Change	-16.25 (4.67)	-16.00 (5.21)
Week 4 Change	-17.58 (4.6)	-23.25 (4.98)
Week 6 Change	-19.33 (3.58)	-25.5 (5.58)

Primary outcome: Relative Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6

Time frame: Baseline (Week 0), Week 2, Week 4 and Week 6. Mean (Standard Deviation). Unit: Percentage change from baseline

Measure	Right-Sided Low-Frequency rTMS n = 12	Left-Sided High-Frequency rTMS n = 8
Week 2(Relative Change)	-61.99 (17.26)	-55.48 (19.23)
Week 4 (Relative change)	-67.80 (18.06)	-78.30 (7.73)
Week 6(Relative change)	-74.53 (15.82)	-85.85 (7.84)

Primary outcome: Number of Participants With Treatment-Emergent Side Effects (UKU)

Time frame: Baseline (Week 0), Week 2, Week 4, and Week 6. Count of participants. Unit: Participants

Measure	Right-Sided Low-Frequency rTMS n = 12	Left-Sided High-Frequency rTMS n = 8
Week 2: Any UKU Cluster	5	3
Week 2: No treatment emergent side effects	7	5
Week 4: Any UKU Cluster	5	2
Week 4: No treatment emergent side effects	7	6
Week 6: Any UKU Cluster	3	1
Week 6: No treatment emergent side effects	9	7

Population analysed: Treatment-Emergent Side Effects show % of participants with worsening of adverse effects

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline, Week 2, Week 4, Week 6. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Right-Sided Low-Frequency rTMS	0 of 12 (0%)	12 of 12 (100%)	0 of 12
Left-Sided High-Frequency rTMS	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Limitations and caveats (from the sponsor): Pilot trial with small number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15695497Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.
Background: PubMed 20439832George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
Background: PubMed 18232722Janicak PG, O'Reardon JP, Sampson SM, Husain MM, Lisanby SH, Rado JT, Heart KL, Demitrack MA. Transcranial magnetic stimulation in the treatment of major depressive disorder: a comprehensive summary of safety experience from acute exposure, extended exposure, and during reintroduction treatment. J Clin Psychiatry. 2008 Feb;69(2):222-32. doi: 10.4088/jcp.v69n0208.
Background: PubMed 21807002Machado S, Paes F, Velasques B, Teixeira S, Piedade R, Ribeiro P, Nardi AE, Arias-Carrion O. Is rTMS an effective therapeutic strategy that can be used to treat anxiety disorders? Neuropharmacology. 2012 Jan;62(1):125-34. doi: 10.1016/j.neuropharm.2011.07.024. Epub 2011 Jul 27.
Background: PubMed 17573044O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.
Background: PubMed 21631403Paes F, Machado S, Arias-Carrion O, Velasques B, Teixeira S, Budde H, Cagy M, Piedade R, Ribeiro P, Huston JP, Sack AT, Nardi AE. The value of repetitive transcranial magnetic stimulation (rTMS) for the treatment of anxiety disorders: an integrative review. CNS Neurol Disord Drug Targets. 2011 Aug;10(5):610-20. doi: 10.2174/187152711796234943.
Background: PubMed 18447962Schutter DJ. Antidepressant efficacy of high-frequency transcranial magnetic stimulation over the left dorsolateral prefrontal cortex in double-blind sham-controlled designs: a meta-analysis. Psychol Med. 2009 Jan;39(1):65-75. doi: 10.1017/S0033291708003462. Epub 2008 Apr 30.
Background: PubMed 20361902Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. doi: 10.4088/JCP.08m04872gre. Epub 2010 Mar 9.
Individual participant dataSharing planned: No

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.

Mehmet Dokucu, MD, PhD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cancer in Remission (Any Type or Stage) and Depression, run by Northwestern University at 1 site in United States.

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 1 inclusion and 1 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 24 Jun 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Change in Depression Severity (HDRS-17) at Weeks 2, 4, and 6 (time frame: Baseline (Week 0), Week 2, Week 4 and Week 6.). The study lists 3 primary outcomes in all. 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 NCT01701284, which also lists 8 linked publications.

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 24 Jun 2026.