Repetitive Transcranial Magnetic Stimulation in Cancer Patients With Depression and Anxiety

NCT01701284 | Completed DMC

• 2 other identifiers: NU 12CC12NCI-2012-01691
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

repetitive Transcranial Magnetic Stimulation; Cancer Survivors; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

  0, 2, 4, and 6 weeks

• 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.

  0, 2, 4, and 6 weeks

• 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.

  0, 2, 4, and 6 weeks

Secondary Outcomes (4)

• Overall change in anxiety severity

  Weekly (starting with week 0 through week 6)

• Relative change in anxiety severity

  Weekly (starting with week 0 through week 6)

• Correlation of anxiety with change in depression severity

  0 and 6 weeks

• Correlation of anxiety with harm avoidance personality trait

  Baseline

Study Arms (2)

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.

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.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Also known as: Neurostar TMS Therapy(R) System

Left-Sided High-Frequency rTMS; Right-Sided Low-Frequency rTMS

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Neuronetics: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

• 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.

  PMID: 15695497 BACKGROUND

• 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.

  PMID: 20439832 BACKGROUND

• 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.

  PMID: 18232722 BACKGROUND

• 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.

  PMID: 21807002 BACKGROUND

• 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.

  PMID: 17573044 BACKGROUND

• 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.

  PMID: 21631403 BACKGROUND

• 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.

  PMID: 18447962 BACKGROUND

• 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.

  PMID: 20361902 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Transcranial Magnetic Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Drug Therapy

Study Officials

• Mehmet Dokucu, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)