Identifying Factors That Predict Antidepressant Treatment Response

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

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2015-04-30

Brief Summary

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

This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.

Related Clinical Trials

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

Imaging Predictors of Treatment Response in Depression

NCT00367341

Major Depressive Disorder

COMPLETED NA

Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression

NCT00200902

Depression

COMPLETED PHASE4

Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder

NCT00810069

Major Depressive Disorder

COMPLETED PHASE4

An Investigation of the Antidepressant Efficacy of the 5-HT2A Antagonist, M100907, in Combination With Citalopram in Treatment Resistant Depression

NCT00070694

Depressive Disorder

COMPLETED PHASE2

Treatment of Depression in Adults

NCT00073697

Depression

COMPLETED PHASE4

Detailed Description

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

Major depressive disorder (MDD) is a serious illness that affects a person's body, mood, and thoughts. The symptoms of MDD can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that were once pleasurable. Antidepressant medications and psychotherapy are among the effective treatments for MDD. Individuals often respond to one type of treatment, but not another. Currently, however, doctors have no way of pre-determining which individuals will most benefit from which treatments. In the absence of practical predictors of MDD treatment response, the potential efficacy of existing MDD treatments is limited. This study will identify factors that may predict MDD treatment response by comparing the effectiveness of a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), and cognitive behavioral therapy in people with MDD.

Participants in this 14-week, double-blind study will be randomly assigned to receive duloxetine (SNRI), escitalopram (SSRI), or cognitive behavioral therapy. During the first 2 weeks of screening, participants will complete questionnaires, clinician evaluations, an electrocardiogram, a personality assessment, a dexamethasone-corticotropin releasing factor test, a functional magnetic resonance imaging scan and provide blood samples. Upon completion of screening, patients will start the treatment to which they were randomized. Duloxetine and escitalopram are two medications that are approved by the Food and Drug Administration for the treatment of depression. Cognitive behavioral therapy is a talking therapy that is also used to treat depression. All participants assigned to take duloxetine or escitalopram will be seen by a study physician weekly for 6 weeks, and then every other week for the remainder of the study. Participants assigned to cognitive behavioral therapy will attend therapy sessions twice a week for the first 4 weeks, and then once a week for the remainder of the study. The following assessments will be performed for all participants at each visit: vital sign and weight measurements; clinician assessments; and self-report questionnaires. Additionally, blood samples will be taken at three visits through the trial and functional magnetic resonance imaging (fMRI) scans will be performed at selected times.

A companion study to the main CIDAR study offers participants further treatment. Participants who achieve remission after the initial 12 weeks of treatment will have the option to enroll in a 21-month follow-up study of maintenance treatment, with visits every three months to monitor for sustained response and relapse. Participants who do not remit will have the option to enroll in another 12-week treatment course, receiving a combination of CBT and medication. Participants who achieve response after this combination treatment will be eligible to receive maintenance combination treatment for up to an additional 18 months, monitored for sustained response and relapse. Participants who do not wish to enroll or continue in the companion study will be provided with a referral for treatment with another mental health provider.

Conditions

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

Depression

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

Escitalopram

Participants will receive treatment with escitalopram for 12 weeks

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

Escitalopram 10 to 20 mg per day for 12 weeks

Duloxetine

Participants will receive treatment with duloxetine for 12 weeks

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Duloxetine 30 to 60 mg per day for 12 weeks

CBT

Participants will receive 16 one-hour sessions of cognitive behavioral therapy delivered over 12 weeks

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

CBT will include 16 one-hour sessions provided over 12 weeks.

Interventions

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

Escitalopram

Escitalopram 10 to 20 mg per day for 12 weeks

Intervention Type DRUG

Duloxetine

Duloxetine 30 to 60 mg per day for 12 weeks

Intervention Type DRUG

Cognitive behavioral therapy (CBT)

CBT will include 16 one-hour sessions provided over 12 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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

Lexapro Cymbalta

Eligibility Criteria

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

Inclusion Criteria

* Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
* Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be criteria for exclusion)
* Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
* Agrees to use an effective form of contraception and/or double barrier method

Exclusion Criteria

* Previously treated for major depression with either medication or psychotherapy
* Current psychosis, dementia, eating disorder, or dissociative disorder
* History of bipolar disorder (I and II) or schizophrenia
* Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening
* Requires neuroleptic or mood stabilizer therapy in addition to depression treatment
* Presence of any acute or chronic medical disorder that could affect successful completion of the trial
* Medical contraindications that would preclude treatment with escitalopram or duloxetine
* Presence of practical issues that would likely prevent completion of the study (e.g., planned geographical relocation)
* Pregnant or breastfeeding
* Medical conditions that could prevent the safe use of MRI (e.g., pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants; steel worker)
* Medical conditions that could prevent the safe completion of a dexamethasone-corticotropin releasing factor (Dex-CRF) test (e.g., uncontrolled hypertension, significant abnormalities in EKG, anemia, known allergies against drugs)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No