Clinical trial NCT01976975: Brain Mechanisms of Human Motivation
Official title: Multi Level Analysis of Positive Valence Systems Across Mood Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Bipolar Disorder
Keywords: Depression
Major Depressive Disorder
Bipolar Disorder
Mania
Hypomania
EEG
MRI
Reward
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We are studying a population with depressive and/or manic or hypomanic symptoms, as well as healthy controls.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Response Bias
timeFrame: Administered during the first session.
measure: Mean Accuracy on Gain Trials During an Instrumental Learning Task
timeFrame: Administered in session 3 during 1.5 hour MR scan
Secondary outcomes:
measure: Symptom Severity at 6 Month Follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Diego A Pizzagalli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: