The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain Derived Neurotropic Factor (BDNF) in Depressed Elders

NCT01305889 | Completed

• 1 other identifier: 10-02704
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of this study is to gather preliminary data regarding the effects of a psychological therapy-Problem Solving Therapy-and an antidepressant medication-sertraline-on 1) cerebral perfusion (CP), 2) brain derived neurotrophic factor (BDNF), and 3) measures of cognitive function in subjects with late life major depression (LLMD). This research goal will be achieved by recruiting 38 individuals over the age of 65 with LLMD. The primary outcomes will be change in CP, change in BDNF, and change in cognitive measures from baseline to the end of 12 weeks of either therapy. We will also examine predictors of treatment outcome including severity of executive dysfunction, baseline BDNF concentrations, and baseline CP measures. The baseline neuropsychological testing, brain imaging, and depression assessment will be obtained in a companion study (PI S. Mackin; CHR #H42689-32681-01) that is IRB approved and is already in progress. In the current study a baseline serum BDNF level will be added to Dr. Mackin's protocol. Patients will then receive either 12 weeks of Problem Solving Therapy or antidepressant treatment with sertraline. Both treatments are evidence based and commonly administered in our clinic. Outcome variables will be measures of depression severity, the BDNF serum concentration, cerebral perfusion using a MRI arterial spin labeling (ASL) technique and cognitive changes in memory and executive dysfunction. This is a preliminary or pilot study. The primary objectives are to determine if the methods appear feasible and to determine if change in BDNF or CP occur after treatment and secondarily to determine if there are changes in cognitive functioning. The study is not powered to show differences between treatments. The hypotheses are 1) PST will result in increased perfusion in frontal regions of the brain but that frontal perfusion will not change with sertraline; 2)sertraline will result in an increase in BDNF but PST will not. Change in cognitive measures of memory, learning, and executive dysfunction will be examined on an exploratory basis.

Conditions

Major Depressive Disorder

Keywords

Depression; Cerebral perfusion; Brain derived neurotropic factor; Problem Solving Therapy; Sertraline

Outcome Measures

Primary Outcomes (1)

• change in cerebral perfusion

  Change in cerebral perfusion from baseline to study endpoint in frontal brain regions.

  study endpoint (8-12 weeks)

Secondary Outcomes (2)

• Change in cognitive measures of memory, learning, and executive dysfunction

  Baseline to study endpoint (8-12 weeks)

• Change in BDNF

  8-12 weeks

Study Arms (2)

problem solving therapy

EXPERIMENTAL

subjects will receive 12 weeks of weekly problem solving therapy

Behavioral: problem solving therapy

sertraline

EXPERIMENTAL

12 weeks of sertraline

Drug: Sertraline

Interventions

problem solving therapy BEHAVIORAL

12 weeks of weekly 45 minute sessions of problem solving therapy

Also known as: PST

problem solving therapy

Sertraline DRUG

12 weeks of sertraline; 25 mg for one week, 50 mg for 3 weeks; then 100 mg/day for 4 weeks; then 150 mg/day for 4 weeks based on tolerability and response

Also known as: SSRI

sertraline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• clinical diagnosis of DSM IV non-psychotic unipolar major depression
• depression severity \> or = to 19 on HDRS
• age 65 years or older
• able to provide informed consent

You may not qualify if:

• history of psychosis
• failure to respond to sertraline or PST during the episode
• allergic to sertraline

Sponsors & Collaborators

• University of California, San Francisco: lead
• Leon J. Epstein Endowment: collaborator

Study Sites (1)

Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• J. Craig Nelson, MD

  Univeristy of California San Francisco, Langley Porter Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• R. Scott Mackin, MD

  Univeristy of California San Francisco, Langley Porter Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 1, 2011
• Study Start: March 1, 2011
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2018
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (1)