Functional MRI Before and After Treatment for Depression

NCT00896441 | Terminated Results

• 2 other identifiers: SU-04202009-2339Stanford IRB #15305
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Mood Disorders; Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale Percent Change From Day 0 to D56

  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

  % change from baseline to Day 56 ( week 8)

• Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex

  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.

  baseline and week 8

Secondary Outcomes (1)

• Hamilton Anxiety Scale

  % change in anxiety from Day 1 to Day 56 (week 8)

Study Arms (2)

Depressed patients

EXPERIMENTAL

Depressed patients assigned in an open-label study of citalopram

Drug: Citalopram

Controls

NO INTERVENTION

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

Interventions

Citalopram DRUG

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.

Depressed patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression; Mood Disorders; Depressive Disorder

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mike Greicius
• Organization: Stanford University

greicius@stanford.edu

650-723-8331

Study Officials

• Michael D Greicius

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 13, 2017
• Results First Posted: October 13, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)