Predictors of Treatment Response in Late-onset Major Depressive Disorder

NCT02546024 | Suspended

• 1 other identifier: 178116/813302/14/153
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Disorder, Major

Keywords

Major depressive disorder; late-onset; treatment response; predictors; moderators

Outcome Measures

Primary Outcomes (1)

• Resting Functional brain MRI

  resting stage functional MRI of brain, eyes closed

  Week 4 after enrollment

Secondary Outcomes (3)

• Neuropsychological test battery

  at entry and endpoint (Week12)

• Structural brain MRI

  Week 4 after enrollment

• Functional assessment

  at entry and endpoint (Week12)

Study Arms (2)

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

Treatment non-responder

Participants who receive standard care but have HAM-D score reduction less than 50% at Week 12.

Drug: Standard care

Interventions

Standard care DRUG

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

Also known as: treatment as usual, antidepressant or psychotherapy

Treatment non-responder; Treatment responder

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Related Publications (2)

• Alexopoulos GS, Hoptman MJ, Kanellopoulos D, Murphy CF, Lim KO, Gunning FM. Functional connectivity in the cognitive control network and the default mode network in late-life depression. J Affect Disord. 2012 Jun;139(1):56-65. doi: 10.1016/j.jad.2011.12.002. Epub 2012 Mar 15.

  PMID: 22425432 BACKGROUND

• Patel MJ, Andreescu C, Price JC, Edelman KL, Reynolds CF 3rd, Aizenstein HJ. Machine learning approaches for integrating clinical and imaging features in late-life depression classification and response prediction. Int J Geriatr Psychiatry. 2015 Oct;30(10):1056-67. doi: 10.1002/gps.4262. Epub 2015 Feb 17.

  PMID: 25689482 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Standard of Care; Therapeutics; Antidepressive Agents; Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Behavioral Disciplines and Activities

Study Officials

• Chavit Tunvirachaisakul

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 31, 2016

Record last verified: 2015-09