NCT01976975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 23, 2019

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

4.3 years

First QC Date

October 25, 2013

Results QC Date

June 1, 2018

Last Update Submit

August 2, 2021

Conditions

Keywords

DepressionMajor Depressive DisorderBipolar DisorderManiaHypomaniaEEGMRIReward

Outcome Measures

Primary Outcomes (2)

  • Change in Response Bias

    The Probabilistic Reward Task (PRT) is a behavioral task that measures an individual's ability to learn to choose a more rewarding outcome versus a less rewarding one (Response Bias). The response bias score is a ratio of the number of times a participant correctly chooses the high reward stimulus (the "rich" stimulus) versus the low reward stimulus (the "lean" stimulus). Response bias scores range between -1 and +1. A higher Response Bias score indicates a stronger bias toward the rich stimulus, and a negative Response Bias indicates a stronger bias toward the lean stimulus. The Change-in-Response-Bias is calculated by subtracting Response Bias in block 1 (trials 0-100) of the task from Response Bias in block 3 (trials 201-300) of the task. This metric represents the degree to which an individual is able to update behavior as a function of the asymmetrical reinforcement schedule.

    Administered during the first session.

  • Mean Accuracy on Gain Trials During an Instrumental Learning Task

    The instrumental learning task requires participants to choose between two abstract symbols. Each symbol in the pair is associated with an 80% or 20% probability of a given outcome (gain: win $1 or $0; loss: lose $1 or $0; neutral: view a gray square or see the word 'nothing'). The task consists of three blocks. Behavioral performance focuses on the number of times the participant chose the symbol that was associated more frequently associated with the more desirable outcome. A participant scores 1 if they choose correctly, and 0 if they choose in correctly, and correct choices across all three blocks are added and converted to a percentage relative to the total number of trials in that condition (i.e., gain, loss, or neutral). This study focused on percent of accuracy responses in the gain condition.

    Administered in session 3 during 1.5 hour MR scan

Secondary Outcomes (1)

  • Symptom Severity at 6 Month Follow-up

    6 months

Study Arms (2)

Mood disorder patients

Patients with depressive and/or manic or hypomanic symptoms

Healthy controls

Participants with no lifetime history of psychiatric illness

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

We are studying a population with depressive and/or manic or hypomanic symptoms, as well as healthy controls.

You may qualify if:

  • 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):
  • weeks for fluoxetine,
  • months for neuroleptics,
  • weeks for benzodiazepines,
  • weeks for any other antidepressants
  • weeks for any mood-stabilizers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderDepressionMania

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
David Crowley
Organization
McLean Hospital

Study Officials

  • Diego A Pizzagalli, Ph.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychiatry, Harvard Medical School

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 6, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

August 4, 2021

Results First Posted

April 23, 2019

Record last verified: 2021-08

Locations