Cholinergic Modulation of Condition and Emotion in Mood Disorders: Functional Neuroimaging Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00055575
First received: March 6, 2003
Last updated: June 10, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Mood Disorders
Healthy
Unipolar Depression
Bipolar Depression
Drug: Transderm Scopolamine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Cholinergic Modulation of Cognition and Emotion in Mood Disorders: Functional Neuroimaging Studies

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Evaluation of the antidepressant effects of the antimuscarinic agent scopolamine [ Time Frame: 5 to 10 years ]

Estimated Enrollment: 388
Study Start Date: February 2003
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Transderm Scopolamine
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Patients with Major Depressive Disorder (MDD):

  • Age 18-55
  • Current diagnosis of MDD, as defined by DSM-IV criteria for recurrent MDD
  • Current depressive episode
  • Current IDS score in the moderately-to-severely depressed range
  • Right handed
  • Able to provide informed consent

Patients with Bipolar Disorder (BD):

  • Age 18-55
  • Current diagnosis of bipolar disorder, as defined by DSM-IV
  • Current depressive episode
  • Current IDS score in the moderately-to-severely depressed range
  • Right handed
  • Able to provide informed consent

Healthy Controls:

  • Age 18-55
  • Able to provide informed consent
  • Medically healthy

EXCLUSION CRITERIA:

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)
  • 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)
  • HIV positive status
  • Weight over 275 pounds

For BD patients being recruited for the scopolamine efficacy trial, they may forgo imaging and thus will not be excluded for imaging related exclusion criteria (including general MRI exclusion criteria and vision and/or hearing problems).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055575

Contacts
Contact: Maura L Furey, Ph.D. (301) 594-7773 mfurey@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Maura L Furey, Ph.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00055575     History of Changes
Other Study ID Numbers: 030108, 03-M-0108
Study First Received: March 6, 2003
Last Updated: June 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Scopolamine
Depression
fMRI
Cognition
Emotion
Brain
Bipolar Disorder
Major Depressive Disorder
MDD
Healthy Volunteer
HV

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms
Scopolamine
Butylscopolammonium Bromide
Cholinergic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics

ClinicalTrials.gov processed this record on July 29, 2014