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Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety (rTMSinCP)

Primary Purpose

Cancer in Remission (Any Type or Stage), Depression, Anxiety

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS)

About this trial

This is an interventional treatment trial for Cancer in Remission (Any Type or Stage) focused on measuring repetitive Transcranial Magnetic Stimulation, Cancer Survivors, Depression, Anxiety

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female
Age 22-80
Had a previous diagnosis of cancer (any type or stage) confirmed by official medical records
Has a DSM IV diagnosis of Major Depressive Disorder
Has a HAM-D 24-item score of more than 20
Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode
All participants must have given signed, informed consent prior to registration in study

Exclusion Criteria:

Participant had breast cancer with brain metastases
There is evidence of the disease at the time of entry into the trial
Presence or recent history of other concurrent cancers, with the following exceptions:
- Participants with completely treated basal or squamous skin cancers can be included in the study if their physicians deem that they are medically stable
- Participants with completely treated in situ carcinoma of the breast or cervix may be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable
- Participants with pre-cancerous lesions in the colon can be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable
Participant had recent surgery (within two weeks)
Participant is undergoing chemotherapy
Participant is pregnant or nursing
Participant has any metallic object in or around their head
Participant has a pacemaker
Has unstable suicidal ideation as determined by the patient's treating psychiatrist
Substance use disorder within the prior six months
Significant history of head injury/trauma as defined by loss of consciousness for more than 1 hour
Recurring seizures resulting from the head injury
Clear cognitive sequelae from the head injury and cognitive rehabilitation following the injury
Any disorder that would predispose the participant to seizures
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 will evaluate the drugs and doses to determine the risks and benefits. These will then be discussed with the individual's Primary Care Physician to determine if the individual should be excluded from the study.

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Right-Sided Low-Frequency rTMS

Left-Sided High-Frequency rTMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall change in depression severity

Overall change in depression severity (as measured by the Hamilton Depression Rating Scale) will be measured for each treatment arm.

Relative change in depression severity

Change in depression severity (as measured by the Hamilton Depression Rating Scale) for a treatment arm will be compared relative to change in depression severity in the other treatment arm.

Presence and changes in severity of side effects

At weeks 2, 4 and 6, UKU Side Effects Rating Scale scores will be compared to baseline UKU scores to determine changes in presence and severity of side effects. Additionally, UKU scores at weeks 2, 4, and 6 will be used to determine probability that side effects are related to intervention.

Secondary Outcome Measures

Overall change in anxiety severity

Overall change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be measured for each treatment arm.

Relative change in anxiety severity

Change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) for a treatment arm will be compared relative to change in anxiety severity in the other treatment arm.

Correlation of anxiety with change in depression severity

Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with change (from baseline to end of week 6) in depression severity (as measured by the Hamilton Depression Rating Scale) for each treatment arm and compared.

Correlation of anxiety with harm avoidance personality trait

Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with Harm Avoidance scores from the TCI personality inventory

Full Information

NCT ID

NCT01701284

First Posted

October 3, 2012

Last Updated

January 11, 2023

Sponsor

Northwestern University

Collaborators

Neuronetics

1. Study Identification

Unique Protocol Identification Number

NCT01701284

Brief Title

Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety

Acronym

rTMSinCP

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2012 (undefined)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Neuronetics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer in Remission (Any Type or Stage), Depression, Anxiety

Keywords

repetitive Transcranial Magnetic Stimulation, Cancer Survivors, Depression, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Right-Sided Low-Frequency rTMS

Arm Type

Experimental

Arm Description

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.

Arm Title

Left-Sided High-Frequency rTMS

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation (rTMS)

Other Intervention Name(s)

Neurostar TMS Therapy(R) System

Primary Outcome Measure Information:

Title

Overall change in depression severity

Description

Overall change in depression severity (as measured by the Hamilton Depression Rating Scale) will be measured for each treatment arm.

Time Frame

0, 2, 4, and 6 weeks

Title

Relative change in depression severity

Description

Change in depression severity (as measured by the Hamilton Depression Rating Scale) for a treatment arm will be compared relative to change in depression severity in the other treatment arm.

Time Frame

0, 2, 4, and 6 weeks

Title

Presence and changes in severity of side effects

Description

Time Frame

0, 2, 4, and 6 weeks

Secondary Outcome Measure Information:

Title

Overall change in anxiety severity

Description

Overall change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be measured for each treatment arm.

Time Frame

Weekly (starting with week 0 through week 6)

Title

Relative change in anxiety severity

Description

Change in anxiety severity (as measured by the Hamilton Anxiety Rating Scale) for a treatment arm will be compared relative to change in anxiety severity in the other treatment arm.

Time Frame

Weekly (starting with week 0 through week 6)

Title

Correlation of anxiety with change in depression severity

Description

Time Frame

0 and 6 weeks

Title

Correlation of anxiety with harm avoidance personality trait

Description

Baseline anxiety severity (as measured by the Hamilton Anxiety Rating Scale) will be correlated with Harm Avoidance scores from the TCI personality inventory

Time Frame

Baseline

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female Age 22-80 Had a previous diagnosis of cancer (any type or stage) confirmed by official medical records Has a DSM IV diagnosis of Major Depressive Disorder Has a HAM-D 24-item score of more than 20 Failed to receive satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current depressive episode All participants must have given signed, informed consent prior to registration in study Exclusion Criteria: Participant had breast cancer with brain metastases There is evidence of the disease at the time of entry into the trial Presence or recent history of other concurrent cancers, with the following exceptions: Participants with completely treated basal or squamous skin cancers can be included in the study if their physicians deem that they are medically stable Participants with completely treated in situ carcinoma of the breast or cervix may be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable Participants with pre-cancerous lesions in the colon can be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable Participant had recent surgery (within two weeks) Participant is undergoing chemotherapy Participant is pregnant or nursing Participant has any metallic object in or around their head Participant has a pacemaker Has unstable suicidal ideation as determined by the patient's treating psychiatrist Substance use disorder within the prior six months Significant history of head injury/trauma as defined by loss of consciousness for more than 1 hour Recurring seizures resulting from the head injury Clear cognitive sequelae from the head injury and cognitive rehabilitation following the injury Any disorder that would predispose the participant to seizures 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 will evaluate the drugs and doses to determine the risks and benefits. These will then be discussed with the individual's Primary Care Physician to determine if the individual should be excluded from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Dokucu, MD, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15695497

Citation

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.

Results Reference

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PubMed Identifier

20439832

Citation

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.

Results Reference

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PubMed Identifier

18232722

Citation

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.

Results Reference

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PubMed Identifier

21807002

Citation

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.

Results Reference

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PubMed Identifier

17573044

Citation

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.

Results Reference

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PubMed Identifier

21631403

Citation

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.

Results Reference

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PubMed Identifier

18447962

Citation

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.

Results Reference

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PubMed Identifier

20361902

Citation

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.

Results Reference

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Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety

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