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Functional MRI Before and After Treatment for Depression

This study has been terminated.
(Funding ended)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896441
First Posted: May 11, 2009
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Keller, Stanford University
  Purpose
The purpose of this study is to help us understand how depression changes brain activity and how this relates to mood, anxiety, and cognitive functions like memory. We also hope to develop a brain imaging test that will predict either before or within two weeks of starting a medicine whether the treatment will work.

Condition Intervention
Depression Mood Disorders Depressive Disorder Drug: Citalopram

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional MRI Before and After Treatment for Depression

Resource links provided by NLM:


Further study details as provided by Jennifer Keller, Stanford University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale Percent Change From Day 0 to D56 [ Time Frame: % change from baseline to Day 56 ( week 8) ]
    Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression

  • Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex [ Time Frame: baseline and week 8 ]
    The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.


Secondary Outcome Measures:
  • Hamilton Anxiety Scale [ Time Frame: % change in anxiety from Day 1 to Day 56 (week 8) ]
    Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.


Enrollment: 31
Study Start Date: February 2009
Study Completion Date: June 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depressed patients
Depressed patients assigned in an open-label study of citalopram
Drug: Citalopram

Refer to Detailed Description Section for full description of intervention. Week 1 (baseline): Subject will complete several tests to assess the subject's memory and concentration. Following visit, they will begin treatment with the antidepressant citalopram.

Week 1 MRI: Subject will have their first MRI. Week 2 visit: Physician will meet with they to assess the subject's overall condition.

Week 2 MRI: Subject will have the subject's second MRI. Week 4 visit: The study physician will meet with the subject to assess their overall condition.

Week 6 (Telephone check-in): The study physician will check in with the subject by telephone to assess the subject's overall condition.

Week 8: (End-of-study visit) Subject will take repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of the subject's depression.

Week 8 MRI: Around the time of the subject's week 8 visit they will have the subject's third and final MRI.

No Intervention: Controls
Healthy controls used as a comparison (no intervention) group for change in resting-state fMRI over time

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients will be aged 18-65, have no significant neurologic history, must meet DSM-IV criteria for a diagnosis of major depression and be free of antidepressant or other psychotropic medication for a minimum of two weeks before enrollment. If a subject is talking psychiatric medication he/she may be weaned off of the medication by their treating physician prior to study enrollment. Such a course of action would only be advised if the current medication was not considered to be of any benefit to the subject. In particular, if a patient is on antidepressant medication which is of benefit, we would not advise tapering off medication -- and subsequent risk of relapse -- in order to participate in the study. The same line of thinking applies to all psychiatric diagnoses and associated medications candidate subjects may be taking.

Exclusion Criteria:

  1. Significant head trauma with loss of consciousness.
  2. Active abuse of alcohol or illegal substances.
  3. Excluded psychiatric diagnoses include: Bipolar Affective Disorder, primary psychotic disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder
  4. Pregnant or nursing women.
  5. Any contraindication to being scanned in the 3T scanner at the Lucas Center such as having a pacemaker or any implanted device that has not been cleared for scanning at 3 Tesla.
  6. Any significant neurologic history (i.e. seizure, stroke, multiple sclerosis).
  7. Use of psychotropic medications within 2 weeks of enrollment.
  Contacts and Locations
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): NCT00896441


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Michael D Greicius Stanford University
  More Information

Responsible Party: Jennifer Keller, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00896441     History of Changes
Other Study ID Numbers: SU-04202009-2339
Stanford IRB #15305 ( Other Identifier: Stanford University Institutional Review Board )
First Submitted: May 7, 2009
First Posted: May 11, 2009
Results First Submitted: October 11, 2016
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents