N/A
Completed N=270
Brain Mechanisms of Human Motivation
Source: ClinicalTrials.gov NCT01976975 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change in Response Bias — .0546; .0787 log-transformed ratio of scores
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.
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 | — |
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. Informational only — not medical advice.