Functional MRI Before and After Treatment for Depression
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Stanford University.
Recruitment status was: Recruiting
Information provided by:
First received: May 7, 2009
Last updated: May 25, 2011
Last verified: May 2011
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Functional MRI Before and After Treatment for Depression
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Significant head trauma with loss of consciousness.
- Active abuse of alcohol or illegal substances.
- Excluded psychiatric diagnoses include: Bipolar Affective Disorder, primary psychotic disorders (Schizophrenia, Schizoaffective disorder), Obsessive-Compulsive Disorder
- Pregnant or nursing women.
- 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.
- Any significant neurologic history (i.e. seizure, stroke, multiple sclerosis).
- Use of psychotropic medications within 2 weeks of enrollment.
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
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Michael D Greicius
||Michael D Greicius, Stanford University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 7, 2009
||May 25, 2011
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Peripheral Nervous System Agents