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Electrophysiological Correlates of Cognition in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998748
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital

Brief Summary:
Biogenetic messages about the etiology of mental illness (e.g., the "chemical imbalance theory" of depression) are increasing but the impact that these have on decision-making and motivation is not yet clear. This study will evaluate the impact of biogenetic feedback on cognitive control and default-mode network functioning, as well as motivation for different psychiatric treatment modalities. Participants with major depressive disorder (MDD) will be instructed that they are being tested for genetic susceptibility to depression and will be randomized to receive feedback that they either do or do not have a genetic predisposition to depression. Before and after receiving this feedback, brain activity will be assessed using high-density electroencephalogram (EEG). The investigators hypothesize that those exposed to the genetic feedback condition will evidence heightened ruminative default mode network activity and perceive medications to be more effective than psychotherapy.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Sham Genetic Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Electrophysiological Correlates of Cognition in Depression
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
This group of participants will receive the feedback that they have a genetic vulnerability to depression.
Other: Sham Genetic Feedback
Participants will be told either that they have or do not have a genetic predisposition to developing depression.

Active Comparator: Control
This group of participants will receive the feedback that they do not have a genetic vulnerability to depression.
Other: Sham Genetic Feedback
Participants will be told either that they have or do not have a genetic predisposition to developing depression.




Primary Outcome Measures :
  1. Default Mode Network Connectivity [ Time Frame: Through study completion (approximately at hour 4 of study) ]
    Resting-state EEG

  2. Error Positivity (Pe) [ Time Frame: Through study completion (approximately at hour 4 of study) ]
    Elicited between 200-500ms following an error


Secondary Outcome Measures :
  1. Treatment Credibility and Expectancy Questionnaire [ Time Frame: Through study completion (approximately at hour 4 of study) ]
    Perceived credibility of medications and psychotherapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-45
  • Written informed consent
  • BDI-II score greater than or equal to 14 (Beck et al.,1996)
  • Right-handed (Chapman & Chapman,1987)
  • Normal or corrected-to-normal vision and hearing
  • Fluency in written and spoken English
  • Absence of any psychotropic medications for at least 2 weeks
  • Absence of any psychotherapy for at least 2 weeks

Exclusion Criteria:

  • Participants with suicidal ideation where study participation is deemed unsafe by the study clinician
  • Serious or unstable medical illness (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic, autoimmune disease, etc.)
  • History of seizures or seizure disorder
  • Patients with psychotic features
  • Current use of other psychotropic drugs
  • Current use of psychotherapy
  • Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication
  • Patients with a lifetime history of electroconvulsive therapy (ECT)
  • Evidence of sickle cell anemia, Raynaud's disease, ulcerative skin diseases, and hemophilia
  • Evidence of significant inconsistencies in self-report measures
  • History or current diagnosis of dementia
  • Illness receiving acute treatment at time of EEG session (e.g., taking antibiotics)
  • Infections illness (either transient or chronic, such as Lyme disease) at time of EEG session
  • Hairstyles that prevent application of the EEG cap (e.g., braids, dread locks, corn rows, recently dyed hair)
  • History of any psychiatric genotyping
  • History of regular marijuana use (5-7x) per week before age 15
  • History of significant head injury of concussion with loss of consciousness of two minutes or more, or head injury with lingering functional/psychological impact
  • Any alcohol-induced blackouts within the past year
  • Any current drug use as assessed by a urine drug test (covering cocaine, cannabinoids, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998748


Contacts
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Contact: Hans S Schroder, PhD 6178552919 hschroder@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Contact: Hans S Schroder, PhD    617-855-2919    hschroder@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
Investigators
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Principal Investigator: Diego A Pizzagalli, PhD Mclean Hospital

Publications:
Haslam, N., & Kvaale, E. P. (2015). Biogenetic Explanations of Mental Disorder: The Mixed-Blessings Model. Current Directions in Psychological Science, 24(5), 399-404.
Beck, A., Steer, R., & Brown, G. (1996). Beck Depression Inventory-II. San Antonio.
Deacon, B. J., & Baird, G. L. (2009). The Chemical Imbalance Explanation of Depression: Reducing Blame at What Cost? Journal of Social and Clinical Psychology, 28(4), 415-435.
Gehring, W., Liu. Y., Orr. J., & Carp. J. (2012). The Error-related negativity (ERN/Ne). In S. J. Luck & E. Kappenman (Eds.), Oxford handbook of event-related potential components (pp. 231-291). New York: Oxford University Press.
Schroder, H. S., Dawood, S., Yalch, M. M., Donnellan, M. B., & Moser, J. S. (2015). The Role of Implicit Theories in Mental Health Symptoms, Emotion Regulation, and Hypothetical Treatment Choices in College Students. Cognitive Therapy and Research, 39(2), 120-139. https://doi.org/10.1007/s10608-014- 9652-6
Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Rumination resconsidered: A psychometric analysis. Cognitive Therapy and Research, 27(3), 247-259. https://doi.org/10.1023/A:1023910315561

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Responsible Party: Diego A. Pizzagalli, Director, Center for Depression, Anxiety and Stress Research, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03998748    
Other Study ID Numbers: 2019P001081
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders