Brain Mechanisms of Human Motivation

NCT ID: NCT01976975

Last Updated: 2021-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mood disorder patients

Patients with depressive and/or manic or hypomanic symptoms

No interventions assigned to this group

Healthy controls

Participants with no lifetime history of psychiatric illness

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Diego A. Pizzagalli

Associate Professor, Department of Psychiatry, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diego A Pizzagalli, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Pizzagalli D, Whitton A, Treadway M, Rutherford A, Kumar P, Ironside M, Kaiser R, Ren B, Dan R. Brain-based graph-theoretical predictive modeling to map the trajectory of transdiagnostic symptoms of anhedonia, impulsivity, and hypomania from the human functional connectome. Res Sq [Preprint]. 2023 Sep 28:rs.3.rs-3168186. doi: 10.21203/rs.3.rs-3168186/v1.

Reference Type DERIVED
PMID: 37841877 (View on PubMed)

Whitton AE, Kumar P, Treadway MT, Rutherford AV, Ironside ML, Foti D, Fitzmaurice G, Du F, Pizzagalli DA. Distinct profiles of anhedonia and reward processing and their prospective associations with quality of life among individuals with mood disorders. Mol Psychiatry. 2023 Dec;28(12):5272-5281. doi: 10.1038/s41380-023-02165-1. Epub 2023 Jul 4.

Reference Type DERIVED
PMID: 37402852 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-P-001352

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Function and EEG
NCT05003076 COMPLETED EARLY_PHASE1
Neural Bases of Motivation
NCT07251816 RECRUITING NA