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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Leon J. Epstein Endowment
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01305889
First received: February 25, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Behavioral: problem solving therapy
Drug: Sertraline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain Derived Neurotropic Factor in Depressed Elders

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • change in cerebral perfusion [ Time Frame: study endpoint (8-12 weeks) ] [ Designated as safety issue: No ]
    Change in cerebral perfusion from baseline to study endpoint in frontal brain regions.


Secondary Outcome Measures:
  • Change in cognitive measures of memory, learning, and executive dysfunction [ Time Frame: Baseline to study endpoint (8-12 weeks) ] [ Designated as safety issue: No ]
    Change assessed on neuropsychological measures of memory, learning, and executive dysfunction

  • Change in BDNF [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
    Change in BDNF from baseline to endpoint (8-12 weeks)


Estimated Enrollment: 38
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: problem solving therapy
subjects will receive 12 weeks of weekly problem solving therapy
Behavioral: problem solving therapy
12 weeks of weekly 45 minute sessions of problem solving therapy
Other Names:
  • problem solving therapy
  • PST
Experimental: sertraline
12 weeks of sertraline
Drug: Sertraline
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
Other Name: SSRI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of psychosis
  • failure to respond to sertraline or PST during the episode
  • allergic to sertraline
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305889

Contacts
Contact: Alana Kivowitz, BA 415.476.7046 Alana.Kivowitz@ucsf.edu
Contact: J. Craig Nelson, MD 415 476 7405 craign@lppi.ucsf.edu

Locations
United States, California
Langley Porter Psychiatric Institute Recruiting
San Francisco, California, United States, 94143
Principal Investigator: J. Craig Nelson, M.D.         
Sub-Investigator: R. Scott Mackin, Ph.D.         
Sub-Investigator: Michael Weiner, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Leon J. Epstein Endowment
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01305889     History of Changes
Other Study ID Numbers: 10-02704
Study First Received: February 25, 2011
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Depression
Cerebral perfusion
Brain derived neurotropic factor
Problem Solving Therapy
Sertraline

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Sertraline
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014