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Treatment, Emotion, and Neuromodulation of Depression (TREND) Study (TREND)

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Theta Burst Stimulation
Sponsored by
Erika Forbes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Positive Affect, Theta Burst Stimulation

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Current Diagnostic and Statistical Manual (DSM-5) Depressive Disorder

Exclusion Criteria:

  • Bipolar disorder (lifetime)
  • Obsessive-compulsive disorder (lifetime)
  • History of psychosis
  • Daily use of nicotine
  • Past-month use of cocaine, amphetamines, Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Ketamine, or gamma-hydroxybutyrate (GHB)
  • Past 6 month substance use disorder
  • Binge drinking (using NIAAA criteria) within the past week, alcohol use in the past 12 hours
  • Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke
  • History of head trauma with a loss of consciousness (e.g., concussion)
  • History of seizures
  • MRI contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body
  • Pregnancy
  • Current use of Clozapine, Bupropion, or prescription stimulants
  • Current use of benzodiazepines or mood stabilizers
  • Body shape/size too large to fit in MRI scanner
  • Claustrophobia
  • Metal in the head or ferromagnetic metal in the rest of the body
  • Implanted medical devices
  • High-risk suicidality

Sites / Locations

  • The University of Pittsburgh, Department of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TBS

Arm Description

In this open-label trial, all participants will undergo 2 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 TBS sessions in 10 visits). The total time of each pair of sessions (including pause between sessions) will be approximately 1 hour, with each session lasting approximately 100 seconds. There is only 1 group and 1 arm of the study. All participants will receive the treatment.

Outcomes

Primary Outcome Measures

depression severity
Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
September 22, 2023
Sponsor
Erika Forbes
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1. Study Identification

Unique Protocol Identification Number
NCT05436379
Brief Title
Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
Acronym
TREND
Official Title
Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erika Forbes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The investigators will administer theta burst stimulation (TBS) in efforts to observe a decrease in severity of reported depression symptoms. A subset of participants will receive positive affect training during this intervention.
Detailed Description
The study has a longitudinal design in which participants complete a baseline assessment, 20 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered twice/day, 5 days/week, for 2 weeks. This procedural design of a shorter treatment duration is based on findings of pattern of improvement and newly developed SAINT protocol. A subset of participants will receive training in enhancing positive affect, with 10 training sessions occurring between pairs of TBS sessions. In this study, "response" to intervention will be defined as a greater than 50% decrease in severity of depression symptoms reported by participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Positive Affect, Theta Burst Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The proposed study will use theta burst stimulation (TBS) in an open-label, non-randomized open study for young adults with depression. The study will include measurement of brain function before and after TBS to investigate treatment mechanisms. A subset of participants will also complete a training to enhance positive emotions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TBS
Arm Type
Other
Arm Description
In this open-label trial, all participants will undergo 2 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 TBS sessions in 10 visits). The total time of each pair of sessions (including pause between sessions) will be approximately 1 hour, with each session lasting approximately 100 seconds. There is only 1 group and 1 arm of the study. All participants will receive the treatment.
Intervention Type
Device
Intervention Name(s)
Theta Burst Stimulation
Intervention Description
TBS, a next-gen form of transcranial magnetic stimulation (TMS), requires shorter duration and frequency of stimulation and provides comparable clinical efficacy to traditional repetitive TMS for depression. Thus it is an appropriate technique for use with young adults with depression. TBS can be delivered safely and effectively on an accelerated schedule with two sessions/day. Based on an earlier (ongoing) study of TBS to dorsomedial prefrontal cortex, investigators will administer TBS to dmPFC over 2 weeks in young adults with depression. Addressing the behavioral aspects of anhedonia and reward processing, a subset of participants will also receive positive affect training. Magnetic resonance imaging will guide the personalized location of TBS and will be used to examine change in frontostriatal circuitry with TBS. This study has the potential to influence development of new treatments for depression and anhedonia, with possible mechanisms in frontostriatal brain function.
Primary Outcome Measure Information:
Title
depression severity
Description
Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current Diagnostic and Statistical Manual (DSM-5) Depressive Disorder Exclusion Criteria: Bipolar disorder (lifetime) Obsessive-compulsive disorder (lifetime) History of psychosis Daily use of nicotine Past-month use of cocaine, amphetamines, Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Ketamine, or gamma-hydroxybutyrate (GHB) Past 6 month substance use disorder Binge drinking (using NIAAA criteria) within the past week, alcohol use in the past 12 hours Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke History of head trauma with a loss of consciousness (e.g., concussion) History of seizures MRI contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body Pregnancy Current use of Clozapine, Bupropion, or prescription stimulants Current use of benzodiazepines or mood stabilizers Body shape/size too large to fit in MRI scanner Claustrophobia Metal in the head or ferromagnetic metal in the rest of the body Implanted medical devices High-risk suicidality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Pogue, B.A.
Phone
4123549297
Email
pogueam@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Email
TMS_Study@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika E Forbes, Ph.D
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Pittsburgh, Department of Psychiatry
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika E Forbes, Ph.D.
Phone
412-383-5438
Email
forbese@upmc.edu
First Name & Middle Initial & Last Name & Degree
Fabio Ferrarelli, MD, Ph.D.
Phone
412-864-1668
Email
ferrarellif@upmc.edu
First Name & Middle Initial & Last Name & Degree
Erika E Forbes, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25450537
Citation
Chung SW, Hoy KE, Fitzgerald PB. Theta-burst stimulation: a new form of TMS treatment for depression? Depress Anxiety. 2015 Mar;32(3):182-92. doi: 10.1002/da.22335. Epub 2014 Nov 28.
Results Reference
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PubMed Identifier
22177980
Citation
Der-Avakian A, Markou A. The neurobiology of anhedonia and other reward-related deficits. Trends Neurosci. 2012 Jan;35(1):68-77. doi: 10.1016/j.tins.2011.11.005. Epub 2011 Dec 15.
Results Reference
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PubMed Identifier
27918562
Citation
Drysdale AT, Grosenick L, Downar J, Dunlop K, Mansouri F, Meng Y, Fetcho RN, Zebley B, Oathes DJ, Etkin A, Schatzberg AF, Sudheimer K, Keller J, Mayberg HS, Gunning FM, Alexopoulos GS, Fox MD, Pascual-Leone A, Voss HU, Casey BJ, Dubin MJ, Liston C. Resting-state connectivity biomarkers define neurophysiological subtypes of depression. Nat Med. 2017 Jan;23(1):28-38. doi: 10.1038/nm.4246. Epub 2016 Dec 5. Erratum In: Nat Med. 2017 Feb 7;23 (2):264.
Results Reference
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PubMed Identifier
26327307
Citation
Dunlop K, Gaprielian P, Blumberger D, Daskalakis ZJ, Kennedy SH, Giacobbe P, Downar J. MRI-guided dmPFC-rTMS as a Treatment for Treatment-resistant Major Depressive Disorder. J Vis Exp. 2015 Aug 11;(102):e53129. doi: 10.3791/53129.
Results Reference
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PubMed Identifier
19577042
Citation
Forbes EE. Where's the fun in that? Broadening the focus on reward function in depression. Biol Psychiatry. 2009 Aug 1;66(3):199-200. doi: 10.1016/j.biopsych.2009.05.001. No abstract available.
Results Reference
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PubMed Identifier
24412087
Citation
Healey KL, Morgan J, Musselman SC, Olino TM, Forbes EE. Social anhedonia and medial prefrontal response to mutual liking in late adolescents. Brain Cogn. 2014 Aug;89:39-50. doi: 10.1016/j.bandc.2013.12.004. Epub 2014 Jan 10.
Results Reference
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PubMed Identifier
25273300
Citation
Kessler RC, Rose S, Koenen KC, Karam EG, Stang PE, Stein DJ, Heeringa SG, Hill ED, Liberzon I, McLaughlin KA, McLean SA, Pennell BE, Petukhova M, Rosellini AJ, Ruscio AM, Shahly V, Shalev AY, Silove D, Zaslavsky AM, Angermeyer MC, Bromet EJ, de Almeida JM, de Girolamo G, de Jonge P, Demyttenaere K, Florescu SE, Gureje O, Haro JM, Hinkov H, Kawakami N, Kovess-Masfety V, Lee S, Medina-Mora ME, Murphy SD, Navarro-Mateu F, Piazza M, Posada-Villa J, Scott K, Torres Y, Carmen Viana M. How well can post-traumatic stress disorder be predicted from pre-trauma risk factors? An exploratory study in the WHO World Mental Health Surveys. World Psychiatry. 2014 Oct;13(3):265-74. doi: 10.1002/wps.20150.
Results Reference
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PubMed Identifier
25915469
Citation
Morgan JK, Shaw DS, Olino TM, Musselman SC, Kurapati NT, Forbes EE. History of Depression and Frontostriatal Connectivity During Reward Processing in Late Adolescent Boys. J Clin Child Adolesc Psychol. 2016;45(1):59-68. doi: 10.1080/15374416.2015.1030753. Epub 2015 Apr 27.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Results Reference
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PubMed Identifier
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Citation
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
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Results Reference
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Treatment, Emotion, and Neuromodulation of Depression (TREND) Study

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