NCT00050700

Brief Summary

The purpose of this study is to use brain imaging technology to examine the role of certain brain receptors and the nervous system chemical acetylcholine in major depression. The cholinergic system involves the regulation of neurotransmitters and the brain receptors to which they bind. Evidence suggests that the cholinergic system may play a role in the development of depression. Acetylcholine is a neurotransmitter that binds to certain brain receptors called muscarinic cholinergic receptors. Cholinomimetic drugs (drugs that stimulate the cholinergic system) often exacerbate depressive symptoms in people with mood disorders and in healthy individuals. This increase in depressive symptoms may be caused by stimulation of muscarinic acetylcholine receptors (mAChRs), but further study is needed to confirm this. This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to study the function of mAChRs in individuals with depression. Participants in this study will undergo a physical examination, psychiatric interviews, neuropsychological tests, PET and MRI scans, and rating scales of depression, anxiety, and negative thinking symptoms. Questions about behavior and functioning will be asked and blood samples will be collected for genetic analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2002

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 17, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2002

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2010

Completed
Last Updated

July 2, 2017

Status Verified

May 14, 2010

First QC Date

December 17, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

PET[18F]FP-TZTPBipolar DisorderMajor Depressive DisorderMuscarinic 2 Receptors

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty subjects (ages 18-45) male and female will be selected, with primary MDD currently depressed as defined by DSM-IV criteria for recurrent MDD and current HDRS score in the moderately-to-severely depressed range (greater than 18) and who have a first degree relative with MDD but no first degree relatives with mania, alcoholism, or antisocial personality disorder.
  • Thirty subjects (ages 18-45) male and female will be selected who meet DSM-IV criteria for bipolar I or II disorder and are currently depressed, with HDRS score in the moderately-to-severely depressed range (greater than 18). Subjects may be inpatients or outpatients. Because effective treatment will not be discontinued for the purposes of this protocol, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order, or other reasons prior to study entry.
  • Thirty subjects (ages 18-45) male and female who have not met criteria for any major psychiatric disorder will be selected. From this large sample a control subject will be matched to each depressed subject for age, gender, handedness and stage of menstrual cycle. The control subjects will have no known first degree relatives with mood disorders.

You may not qualify if:

  • Subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular function for at least 3 weeks (8 weeks for fluoxetine and for any drug with known anticholinergic effects) prior to scanning. Because effective medications will not be discontinued for the purposes of this study, subjects will be identified who have never been treated or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reasons prior to study entry. Subjects will also be excluded if they: a) serious suidical ideation or behavior - 1) thoughts of suicide within the past three months which are accompanied by intet to harm oneself, serious consideration of means or plan to attempt suicide, evidence of arranging for a suicide attemp (e.g. giving away prized possessions, updating a will) or clear desire to commit suicide; 2) suicide attempts within the previous one year; or 3) a current plan to inflict self harm or physical evidence suspicious for having engaged in a suicide attempt.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Allen TG. The role of N-, Q- and R-type Ca2+ channels in feedback inhibition of ACh release from rat basal forebrain neurones. J Physiol. 1999 Feb 15;515 ( Pt 1)(Pt 1):93-107. doi: 10.1111/j.1469-7793.1999.093ad.x.

    PMID: 9925881BACKGROUND
  • Arango V, Underwood MD, Boldrini M, Tamir H, Kassir SA, Hsiung S, Chen JJ, Mann JJ. Serotonin 1A receptors, serotonin transporter binding and serotonin transporter mRNA expression in the brainstem of depressed suicide victims. Neuropsychopharmacology. 2001 Dec;25(6):892-903. doi: 10.1016/S0893-133X(01)00310-4.

    PMID: 11750182BACKGROUND
  • Baratti CM, Opezzo JW, Kopf SR. Facilitation of memory storage by the acetylcholine M2 muscarinic receptor antagonist AF-DX 116. Behav Neural Biol. 1993 Jul;60(1):69-74. doi: 10.1016/0163-1047(93)90742-z.

    PMID: 8216161BACKGROUND

MeSH Terms

Conditions

DepressionBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental DisordersDepressive Disorder

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 17, 2002

First Posted

December 18, 2002

Study Start

December 16, 2002

Study Completion

May 14, 2010

Last Updated

July 2, 2017

Record last verified: 2010-05-14

Locations