N/A
N=270
Brain Mechanisms of Human Motivation
Major Depressive Disorder · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01976975 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change in Response Bias — .0546; .0787 log-transformed ratio of scores
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Response Bias |
.0546; .0787 | — |
| PRIMARY Mean Accuracy on Gain Trials During an Instrumental Learning Task |
16.65; 17.03 | — |
| SECONDARY Symptom Severity at 6 Month Follow-up |
15.24; .33; 1.41; .07; 39.41; 47.63 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01976975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.