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Predictors of Treatment Response in Late-onset Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT02546024
Recruitment Status : Suspended (Revision of recruitment strategies due to difficulties in recruitment)
First Posted : September 10, 2015
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:

Depression is a common disorder, especially in old age, where it is associated with significant morbidity and mortality.

This study will investigate whether there are features of individual patients with major depression that may predict positive treatment response. The study will invite 40 patients who have been diagnosed with major depressive disorder with onset after the age of 60 years to participate. Participants will be recruited from the Mental Health of Older Adults services at the South London and Maudsley NHS Mental Health Foundation Trust. Participants will receive usual treatment as set out in standard Care Pathways, used by the clinical care team. As part of the study, they will undergo a short battery of neuropsychological tests and a standard MRI brain imaging protocol. The neuropsychological tests and assessment of depression severity will be carried out twice (at Baseline and Week 12). Data will be analysed to investigate whether there are features specific to those patients who show a good response to antidepressant treatment after 12 weeks. Identification of such predictors may help to stratify treatment approaches in the future and lead to the early identification of individual patients who may require alternative treatment approaches to standard antidepressants.


Condition or disease Intervention/treatment
Depressive Disorder, Major Drug: Standard care

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Treatment Response in Late-onset Major Depressive Disorder
Study Start Date : September 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment responder
Participants who receive standard care and achieve HAM-D score reduction of 50% or more, or score below 8 at Week 12.
Drug: Standard care
Standard care according to Care Pathway for depression by Mental Health of Older Adults Services Clinical Academic Group of the South London and Maudsley NHS Foundation Mental Health Trust
Other Names:
  • treatment as usual
  • antidepressant or psychotherapy

Treatment non-responder
Participants who receive standard care but have HAM-D score reduction less than 50% at Week 12.
Drug: Standard care
Standard care according to Care Pathway for depression by Mental Health of Older Adults Services Clinical Academic Group of the South London and Maudsley NHS Foundation Mental Health Trust
Other Names:
  • treatment as usual
  • antidepressant or psychotherapy




Primary Outcome Measures :
  1. Resting Functional brain MRI [ Time Frame: Week 4 after enrollment ]
    resting stage functional MRI of brain, eyes closed


Secondary Outcome Measures :
  1. Neuropsychological test battery [ Time Frame: at entry and endpoint (Week12) ]
    Tests for motor speed, working memory, fluency and task switching

  2. Structural brain MRI [ Time Frame: Week 4 after enrollment ]
    Voxel based morphometry, White matter hyperintensity

  3. Functional assessment [ Time Frame: at entry and endpoint (Week12) ]
    WHODAS 2.0



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 participants with major depressive disorder will be recruited from Community Mental Health Services, Home Treatment Service, and Inpatient services of the Mental Health of Older Adults and Dementia Clinical Academic Group in the South London and Maudsley NHS Foundation Mental Health Thrust.
Criteria

Inclusion Criteria:

  • The participant is 60 or more years old at the point of first contact with psychiatric specialist services for depression.
  • Satisfies diagnostic criteria for current major depressive disorder according to DSM-IV TR (American Psychiatric Association, 2000)
  • Mini-Mental State Examination (MMSE) score of 25 or greater.

Exclusion Criteria:

  • Previously diagnosed with other major psychiatric illness (schizophrenia, bipolar disorder, benzodiazepine/ substance dependence or personality disorder) or registered intellectual disability.
  • Severe or unstable medical condition e.g. severe infection, myocardial infarction, renal failure or metastatic cancer. Including those who have stroke, epilepsy, delirium within 3 months, neurodegenerative disease or dementia.
  • History of traumatic brain injury with more than 10 minutes of loss of conscious period.
  • Metal implants that would be a contraindication for MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546024


Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
Principal Investigator: Chavit Tunvirachaisakul King's College London

Publications:
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02546024     History of Changes
Other Study ID Numbers: 178116/813302/14/153
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: September 2015

Keywords provided by King's College London:
Major depressive disorder
late-onset
treatment response
predictors
moderators

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms