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Serotonin Transporter Density in Late-life Depression With and Without Dementia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01548937
First received: December 29, 2011
Last updated: March 6, 2012
Last verified: October 2011
History of Changes
  Purpose

This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive); each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

This study is expected to be completed in a period of 3 years.


Condition Intervention Phase
Melancholia
 Drug: I-123 ADAM
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Serotonin Transporter Density in Late-life Depression With and Without Dementia

Resource links provided by NLM:

MedlinePlus related topics: Dementia Depression
Drug Information available for: Serotonin
U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia. [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    To expand the database of I-123 ADAM SPECT imaging in AD depressive and cognitively depressive patients to refine the definition of a positive scan in patient with AD and MDD.


Secondary Outcome Measures:
  • Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter. [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    To expand the safety database of I-123 ADAM SPECT imaging Safety variables include adverse event count, lab parameters, vital signs, and ECG. Comparison will be generally made to baseline, as appropriate.


Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I-123 ADAM
I-123 ADAM Serotonin transporter imaging
 Drug: I-123 ADAM

This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive), Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Other Name: I-123 ADAM

Detailed Description:

Depression and dementia are the two common psychiatric disorders in the elder subjects. Alzheimer's disease (AD) is the most frequent cause of dementia and about 20% of them have depression. Depression subjects are associated with more rapid cognitive decline, a poorer response to treatment. Post mortem study showed close relationship between AD and disruptions of the serotonergic system, including loss of serotnergic neurons at brain stem. However, the alternations in presynaptic serotonin function relative to demented or non-demented subjects remain to be investigated in living subjects. In this study, the investigators will collect 40 elder subjects (i.e., age above or equal to 50 years old). The serotonin transporter activity will be compared between subjects with or without dementia using I-123 ADAM images. The single photon emission tomography (SPECT) will be compared to recent (within 6 months) F-18 FDG PET images for further investigation.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients may be enrolled in the AD depressive group if they:

    • Are males or females at least 50 years of age;
    • Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI interview.
    • Meet the NINCDS/ADRDA(National institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association) criteria for probable AD
    • A Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive;
    • Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  2. Patients may be enrolled in the cognitively depressive group if they:

    • Are males or females at least 50 years of age;
    • Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI interview.
    • Memory function above the lower normal limits (i.e. 1.5 SD above the mean) on tests for episodic memory.
    • Clinical Dementia Rating = 0. Memory Box score must be 0.
    • Cognitively normal, based on an absence of significant impairment in cognitive functions or ADL.
    • A MMSE score at screening > 24 for those with education level of 6 years or above and > 17 for those are illiterate;
    • Give informed consent.

Exclusion Criteria:

  • Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
  • Conditions affecting brain structure or function (e.g., stroke, diabetes, head trauma, depression) or use of cognitively
  • Substance abuse.
  • Alcohol dependence
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01548937     History of Changes
Other Study ID Numbers: 98-2132A
Study First Received: December 29, 2011
Last Updated: March 6, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
I-123 ADAM Serotonin transporter imaging

Additional relevant MeSH terms:
Dementia
Depression
Depressive Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
 Mood Disorders
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013