Cholinergic Modulation of Condition and Emotion in Mood Disorders: Functional Neuroimaging Studies
Stopped early · Phase 2
Conditions studied: Mood Disorders, Healthy, Unipolar Depression, Bipolar Depression
In brief
This study looks at the role of a specific brain chemical system in the mood and attention symptoms seen in major depression and bipolar disorders using functional brain imaging.
Key facts
- Study ID
- NCT00055575
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 197
- Starts
- 2003-02-27
- Expected to finish
- 2015-02-02
- Last updated by the study team
- 2021-03-22
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Patients MDD \& BD:
- Serious suicidal ideation or behavior (with a current plan or intent), or current delusions or hallucinations
- Medical or neurological illnesses likely to affect physiology or anatomy
- History of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria)
- Current or past history of other axis I disorders that preceded the onset of MDD or BD
- Current pregnancy (documented by pregnancy testing within 24 hours prior to pilot studies and 24 hours prior to scanning)
- Current breast feeding
- General MRI exclusion criteria (including the presence of pacemakers, cochlear implants, surgical clips or metal fragments in their eyes or body parts)
- Vision and/or hearing problems severe enough to interfere with testing
- Electrocardiographic evidence of ischemia, arrhythmia, conduction defect, or myocardial infarction
- Current blood pressure of >140 mm Hg or < 90 mm Hg systolic, or > 90 mm Hg diastolic (due to the potential cardiovascular effects of scopolamine and physostigmine)
- Clinically significant cerebrovascular or cardiovascular disease, hypertension, congestive heart disease, angina pectoris, advanced arteriosclerosis, gross neurological impairment, hyperthyroidism, known hypersensitivity or idiosyncrasy to anticholinergic agents, glaucoma, renal or hepatic impairment
- Clinical history of glaucoma or narrow angle glaucoma (due to the possibility of exacerbation of this condition by scopolamine)
- Age of onset greater than 45 years (to reduce the biological heterogeneity encompassed by the MDD and BD criteria, since subjects with a late age-at onset for depression have a far greater likelihood of having MRI correlates of cerebrovascular disease than age-matched, healthy controls or age-matched, early-onset depressives)
- Exposure within two weeks to medications likely to effect cerebral blood flow and metabolism or likely to interact with anti-cholinergic medications (e.g. narcotics or anti-cholinergic agents)- as verified by history and urine drug screen
- HIV positive status
- Weight over 275 pounds
- Healthy Controls:
- Medical or neurological illness
- Current pregnancy (documented by pregnancy testing within 24 hours prior to pilot studies and 24 hours prior to scanning)
- Current breast feeding
- General MRI exclusion criteria (including the presence of pacemakers, cochlear implants, surgical clips or metal fragments in their eyes or body parts)
- Vision and/or hearing problems severe enough to interfere with testing
- Electrocardiographic evidence of ischemia, arrhythmia, conduction defect, or myocardial infarction
- Current blood pressure of >140 mm Hg or < 90 mm Hg systolic, or > 90 mm Hg diastolic (due to the potential cardiovascular effects of scopolamine and physostigmine)
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.