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Brain Mechanisms of Human Motivation

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ClinicalTrials.gov Identifier: NCT01976975
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital

Brief Summary:
This study aims to investigate reward learning across the mood disorder spectrum and to investigate the predictive validity of reward learning for subsequent symptom severity.

Condition or disease
Major Depressive Disorder Bipolar Disorder

Detailed Description:
The study involves five sessions. In the first session, participants will play a computer task. In the second session, participants will go through a clinical interview and will have an EEG recording while playing another computer task. In the third session, participants will undergo an fMRI scan while playing another computer task. All tasks assess reward learning. At three and six months after the final session, participants will come back for a follow-up interview session during which a clinician will assess symptom severity. There will be no intervention in this study.

Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Multi Level Analysis of Positive Valence Systems Across Mood Disorders
Study Start Date : October 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

Group/Cohort
Mood disorder patients
Patients with depressive and/or manic or hypomanic symptoms
Healthy controls
Participants with no lifetime history of psychiatric illness



Primary Outcome Measures :
  1. Behavioral Performance in Probabilistic Reward Task [ Time Frame: Given once during the second session for a total of 10 minutes ]
    The probabilistic reward task is designed to measure sensitivity to reward and reward learning. It will be administered three times during session 1 to calculate changes in reward sensitivity.

  2. Behavioral Performance in Instrumental Learning Task [ Time Frame: Administered in session 3 during two hour long scan ]
    The instrumental learning task is designed to measure participant learning from reward and punishment.


Secondary Outcome Measures :
  1. Symptom severity [ Time Frame: 6 months ]
    Participants will report on the phone about their symptom severity after completing all sessions.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We are studying a population with depressive and/or manic or hypomanic symptoms, as well as healthy controls.
Criteria

Inclusion Criteria:

  • Written informed consent
  • Right-handed
  • (For mood disorder group only) Stable medication over the past 8 weeks OR absence of any psychotropic medications for at least 2 weeks (for follow-up analyses testing effects in medication-free patients):

    • 6 weeks for fluoxetine,
    • 6 months for neuroleptics,
    • 2 weeks for benzodiazepines,
    • 2 weeks for any other antidepressants
    • 4 weeks for any mood-stabilizers

Exclusion Criteria:

  • Suicidal ideation where outpatient treatment is determined unsafe by the study clinician
  • Pregnant women or women of childbearing potential who 1) have not completed a negative urine pregnancy test prior to the MRI scan and/or 2) are seeking to become pregnant or believe that they may be pregnant
  • Serious/unstable medical illness (e.g., cardiovascular, renal, endocrine, neurologic disease)
  • Clinical or laboratory evidence of hypothyroidism
  • History of seizure disorder, history or current diagnosis of dementia, score < 26 on the MMSE at screening
  • History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder NOS, patients with mood congruent or mood incongruent psychotic features, anorexia nervosa, obsessive compulsive disorder
  • Lifetime history of stimulant dependence (e.g., cocaine, amphetamines)
  • Current use of Methylphenidate (Ritalin) and other ADHD medications with dopaminergic effects
  • Patients with a lifetime history of electroconvulsive therapy (ECT)
  • Failure to meet standard MRI safety requirements

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): NCT01976975


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Diego A Pizzagalli, Ph.D. Mclean Hospital

Responsible Party: Diego A. Pizzagalli, Associate Professor, Department of Psychiatry, Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01976975     History of Changes
Other Study ID Numbers: 2013-P-001352
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Diego A. Pizzagalli, Mclean Hospital:
Depression
Major Depressive Disorder
Bipolar Disorder
Mania
Hypomania
EEG
MRI
Reward

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Bipolar and Related Disorders