Functional MRI Before and After Treatment for Depression
Recruitment status was Recruiting
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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 |
- Hamilton Depression Rating Scale [ Time Frame: end of 8 week period ] [ Designated as safety issue: Yes ]
- 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) |
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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.
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
- 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.
Contacts and Locations| Contact: Maureen H Chang, B.S. | (650) 725-4620 | mhchang@stanford.edu |
| 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 | |
| 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 May 16, 2013