Brain Imaging Techniques That Predict Antidepressant Responsiveness

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physiologic Monitoring of Antidepressant Response

NCT00792168

Major Depression

COMPLETED PHASE4

Physiologic Monitoring of Antidepressant Treatment Response

NCT00759317

Depression

COMPLETED PHASE4

Effect of Antidepressants on White Matter Structure

NCT01492621

Major Depression

UNKNOWN PHASE4

Study of the Effects of an Antidepressant Medication and Placebo on the Brain Functioning of Normal Subjects

NCT00634283

Depression

COMPLETED PHASE4

Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

NCT01485887

Major Depressive Disorder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

1. Forty participants who have a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM-IV-TR) 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 In the event of suicidal ideation, subjects will be withdrawn from the study and referred for immediate treatment.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 magnetic resonance imaging (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 functional magnetic resonance imaging (fMRI)s 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Depressed; Venlafaxine treatment

Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT). Dosage 75-300mg/day for up to 6 months.

Group Type ACTIVE_COMPARATOR

Venlafaxine ERT

Intervention Type DRUG

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.

Depressed; Fluoxetine treatment

Currently depressed subjects; Randomized medication treatment with Fluoxetine tablets. Dosage 20-80mg/day for up to 6 months.

Group Type ACTIVE_COMPARATOR

Fluoxetine

Intervention Type DRUG

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

Control

Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Effexor ER Prozac

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 central nervous system (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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes