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Brain Imaging Techniques That Predict Antidepressant Responsiveness (WyethKolden)

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00909155
First received: May 18, 2009
Last updated: April 5, 2010
Last verified: April 2010
History of Changes
  Purpose

Do functional brain changes occur during Venlafaxine ER (extended release) versus Fluoxetine treatment and do changes in selective structures, such as the amygdala, predict treatment response?


Condition Intervention
Major Depressive Disorder
 Drug: Venlafaxine ERT
Drug: Fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Non-Invasive Brain Imaging Techniques That Predict Antidepressant Responsiveness and Provide Insights Into the Mechanism of Action of Venlafaxine ER vs. Fluoxetine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating scales [ Time Frame: Study entry, 2 months, and at end of study (6 mos) ] [ Designated as safety issue: No ]
  • fMRI response to an emotional regulation task. [ Time Frame: At study entry, 2 months and end of study (6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vitals [ Time Frame: each visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: July 2002
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT
 Drug: Venlafaxine ERT
Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d.
Other Name: Effexor ER
Active Comparator: 2
Currently depressed subjects; Randomized medication treatment with Fluoxetine
 Drug: Fluoxetine
Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d
Other Name: Prozac
No Intervention: Control
Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication

Detailed Description:

This is a single site, controlled, double-blind study of outpatients. There are two arms:

  1. Forty participants who have a current DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised) diagnosis of Major Depression will be recruited. These subjects will be randomized to receive one of two antidepressant medications: Fluoxetine or Venlafaxine ER for the duration of the study. Subjects will gradually be titrated onto the medications and will be seen in the clinic up to 18 times for medication checks, to monitor side effects and depressive symptoms, including suicidal ideation. In the event of suicidal ideation, subjects will be withdrawn from the study and referred for immediate treatment.
  2. Twenty normal control subjects with no current or past DSM-IV-TR diagnosis and will receive no medication. Normal control subjects will have up to 5 visits while in the study.

Subjects will contact study staff to complete a phone screen and then eligible subjects will complete a clinic screen. Subjects will then be scheduled to attend the MRI simulation visit and if subjects continue to meet entrance criteria, they will be scheduled for the first MRI. Following the first MRI, subjects in the medication conditions will begin receiving medication.

All subjects will undergo 3 fMRIs during the study: at the beginning of the study, approximately 8 weeks and 26 weeks later. During the MRI, subjects will view slides with positive and negative emotional content. Subjects will complete various clinical interviews or rating scales assessing mood and side effects at each of the visits.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Intervention Group:

    • Right-handed,
    • Be able to lie still on their back for about 120 minutes,
    • Meet DSM-IV criteria for major depression (single or recurrent),
    • Have had depressive symptoms for at least 1 month prior to screen visit,
    • Must score an 18 or above on the Hamilton-D at both the initial screening visit and first fMRI scanning session,
    • Able to understand and speak English.
  • Control Group: same as above with the exception of no diagnosis of psychiatric disorder.

Exclusion Criteria:

  • Any history of seizures,
  • Current medical disorders that might make interpretation of scan data difficult,
  • Diabetes requiring insulin treatment,
  • A serious heart disorder or subjects who have had a heart attack within the last 3 months,
  • Subjects who meet DSM-IV criteria for alcohol/drug abuse or dependence within the last six months,
  • Other current DSM-IV Axis I or Axis II diagnoses,
  • A personal or family history of bipolar disorder,
  • Current use of medication that affects CNS function,
  • Participation in the last 30 days in a clinical study involving an investigational drug,
  • A subject with metallic implants, such as prostheses, shrapnel or aneurysm clip-S, or persons with electronic implants, such as cardiac pacemakers. The magnetic field generated by the MRI machine can cause a displacement or malfunctioning of these devices.
  • A subject who is claustrophobic,
  • Female subjects who are pregnant,
  • A subject at serious risk for suicide,
  • Diagnosis of cancer in the past 3 years and/or has active neoplastic disease,
  • Nonresponse to 2 adequate trials of antidepressant treatment,
  • Nonresponse to 2 adequate trials of an empirically supported psychotherapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909155

Locations
United States, Wisconsin
University of Wisconsin Madison Psychiatry Department
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
University of Wisconsin, Madison
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Gregory Kolden, Ph.D. University of Wisconsin Madison Psychiatry Department
Principal Investigator: Michael Peterson, MD, Ph.D. University of Wisconsin Madison Psychiatry Department
  More Information

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gregory Kolden, Ph.D., University of Wisconsin Madison Psychiatry Department
ClinicalTrials.gov Identifier: NCT00909155     History of Changes
Other Study ID Numbers: 0600B-100953
Study First Received: May 18, 2009
Last Updated: April 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Fluoxetine
Venlafaxine
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
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on June 17, 2013