Functional MRI Before and After Treatment for Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00896441
First received: May 7, 2009
Last updated: May 25, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Stanford University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: end of 8 week period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MADRS Rating Scale [ Time Frame: end of 8 week period ] [ Designated as safety issue: Yes ]
  • Hamilton Anxiety Scale [ Time Frame: end of 8 week period ] [ Designated as safety issue: Yes ]
  • Beck Depression Inventory (BDI) [ Time Frame: end of 8 week period ] [ Designated as safety issue: Yes ]
  • Beck Anxiety Scale [ Time Frame: end of 8 week period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Hide Detailed Description

Detailed Description:

You were selected as a possible participant because you are suffering from a major depressive episode, and you have not previously tried the medication used in this study to treat depression. Approximately 60 subjects will participate in this study: 30 subjects who are currently suffering from a major depressive episode and 30 subjects who have never suffered from a major depressive episode.

If you choose to participate, you will be seen at the clinic for a total of five times plus three MRI scans. You will be seen once for a screening visit. If you choose to enroll, you will return a week later for the baseline visit and again at weeks 2, 4 and 8. Around the time of week one (baseline), week 2 and week 8 you will also undergo an MRI scan of the brain.

Screening Visit: The study physician and the research study staff will first screen you for eligibility. The screening visit includes meeting with a physician for a discussion of your medical history and current medications, taking your blood pressure, and checking your weight. Women of childbearing potential will also have a urine pregnancy test. You will meet with a member of the research staff for an interview to collect information about your depression and other psychiatric symptoms you have experienced. The purpose of the interview is to confirm your diagnosis and assess the current severity of your depression. The screening visit will take approximately 2 hours.

Week 1 (baseline): If you are eligible to continue with the study, you will return to the clinic within 7 days for a baseline visit. At your baseline visit, you will complete several tests to assess your memory and concentration. These tests are being conducted because problems with memory and concentration are common in people who are depressed and the researchers want to find out if there is a difference in your memory and concentration before and after taking the study medication. We also wish to compare the results to any findings from the brain imaging. Following the baseline visit, you will begin treatment with the antidepressant citalopram. The starting dose is 20 mg once per day.

Week 1 MRI: Around the time of your week one (baseline) visit and before starting medications, you will have your first MRI.

Week 2 visit: At the end of your second week, the study physician will meet with you to assess your overall condition. Your antidepressant medication will be counted to verify that you have been taking it as prescribed. Your dose will likely not change, but it is possible that it will be increased to as much as 40 mg. If you are experiencing side effects, your dose may be decreased. We will provide you with enough medication to last until your next visit.

Week 2 MRI: Around the time of your week 2 visit you will have your second MRI.

Week 4 visit: The study physician will meet with you to assess your overall condition. Your antidepressant medication will be counted to verify that you have been taking it as prescribed. The dose may be left unchanged, increased up to a total of 40 mg daily or decreased, if you are experiencing side effects (to a minimum of 20 mg daily). You will also be asked about any other medications you have taken since your last visit. We will provide you with enough medication to last until your next visit.

Week 6 (Telephone check-in): The study physician will check in with you by telephone to assess your overall condition. The dose of the citalopram may be left unchanged, increased to a maximum of 60 mg daily or decreased (to a minimum to 20 m daily) if you are experiencing side effects.

Week 8: (End-of-study visit) In addition to the usual visit procedures, the end-of-study visit will include repeated tests of memory and concentration. The study physician will also discuss recommendations for further treatment of your depression. No study medication will be dispensed at this visit.

Week 8 MRI: Around the time of your week 8 visit you will have your third and final MRI.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT00896441

Contacts
Contact: Maureen H Chang, B.S. (650) 725-4620 mhchang@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Maureen H Chang, B.S.    650-725-4620    mhchang@stanford.edu   
Contact: Jessica Hawkins, B.S.    (650) 723-8323    jhawk@stanford.edu   
Principal Investigator: Michael D Greicius         
Sub-Investigator: Matthew White         
Sub-Investigator: Charles DeBattista         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Michael D Greicius Stanford University
  More Information

No publications provided

Responsible Party: Michael D Greicius, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00896441     History of Changes
Other Study ID Numbers: SU-04202009-2339, 15305
Study First Received: May 7, 2009
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 29, 2014