NCT00576875

Brief Summary

The proposed Silvio O. Conte Center for Neuroscience of Depression will focus on understanding the neurobiological mechanism of depression. A total of 5 projects are proposed. The center is focused on a single hypothesis. The first project examines localization of lesions, structural changes in critical regions subserving the circuit, alterations in the white matter tracts relevant to the circuit and changes in glutamate. The second project uses post mortem cell counting and cellular localization in serotonin receptors and assessment of the type of cell loss in the orbitofrontal cortex. The third project uses cognitive paradigms and functional MRI to probe the circuit and the role of brain lesions and serotonin on the functioning of this circuit. The fourth project uses transgenic and knockout mice to examine to role of norepinephrine and serotonin as it relates to the circuit. The final project is designed to assess in these transgenic mice using multielectrode array of single neuron recordings of the firing pattern of the circuit neurons in various states and tasks and the role of monoamines in modulating this circuit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
795

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

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

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

4.9 years

First QC Date

December 18, 2007

Last Update Submit

February 20, 2012

Conditions

Keywords

DepressionElderlyNeuroimagingPostmortemKnockout mouse

Outcome Measures

Primary Outcomes (1)

  • Each of the projects in the Duke Conte Center has its own aims and primary outcomes

    Up to five years

Study Arms (2)

Depressed

Older individuals with major depression

Non-depressed

Older individuals without major depression

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic; Outpatient psychiatry clinic; Inpatient psychiatry clinic; Self-referral

You may qualify if:

  • For depressed group:
  • Age \> 60 years
  • Major depression, single episode or recurrent
  • Ability to read and write English
  • MMSE \>25
  • Willingness to participate in the follow-up study for at least two years.
  • For non-depressed group:
  • Age \> 60 years
  • Ability to read and write English
  • MMSE \>25
  • Willingness to participate in the follow-up study for at least two years

You may not qualify if:

  • Lifetime alcohol or drug dependence
  • Conditions associated with MRI abnormalities such hydrocephalus, benign and cancerous brain tumors, epilepsy, Parkinson's disease, Huntington's chorea, dementia, demyelinating diseases, etc.
  • Endocrine disorder (other than diabetes mellitus)
  • Any physical or intellectual disability that may affect completion of self rating instruments
  • Established clinical diagnosis of dementia
  • Other primary psychiatric disorders, including panic disorder, social phobia, OCD, non-affective psychosis (including schizo-affective disorder), schizophrenia, bipolar disorder
  • Any metal or pacemaker in the body which precludes MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for DNA; Post-mortem brain tissue

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Ranga R Krishnan, MB, ChB

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

August 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations