NCT00360399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 28, 2016

Completed
Last Updated

August 30, 2016

Status Verified

July 1, 2016

Enrollment Period

8.7 years

First QC Date

August 2, 2006

Results QC Date

June 16, 2016

Last Update Submit

July 27, 2016

Conditions

Depression

Keywords

EscitalopramDuloxetineCognitive Behavioral TherapyPETfMRI

Outcome Measures

Primary Outcomes (2)

  • Remission From Major Depressive Episode in Intent to Treat Sample

    The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.

    Up to 12 Weeks

  • Remission From Major Depressive Episode Among Participants Who Completed the Intervention

    The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.

    Measured at Weeks 10 and 12

Secondary Outcomes (4)

  • Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample

    Up to 12 Weeks

  • Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention

    Measured at Weeks 10 and 12

  • Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment

    Measured at 6, 9, 12, 15, 18, 21, and 24 months

  • Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy

    Measured after 12 weeks of combined treatment

Study Arms (3)

Escitalopram

ACTIVE COMPARATOR

Participants will receive treatment with escitalopram for 12 weeks

Drug: Escitalopram

Duloxetine

ACTIVE COMPARATOR

Participants will receive treatment with duloxetine for 12 weeks

Drug: Duloxetine

CBT

ACTIVE COMPARATOR

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

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

EscitalopramDRUG

Escitalopram 10 to 20 mg per day for 12 weeks

Also known as: Lexapro
Escitalopram
DuloxetineDRUG

Duloxetine 30 to 60 mg per day for 12 weeks

Also known as: Cymbalta
Duloxetine
Cognitive behavioral therapy (CBT)BEHAVIORAL

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

CBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV)
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Mood and Anxiety Disorders Program

Atlanta, Georgia, 30306, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Related Publications (6)

  • Dunlop BW, Binder EB, Cubells JF, Goodman MM, Kelley ME, Kinkead B, Kutner M, Nemeroff CB, Newport DJ, Owens MJ, Pace TW, Ritchie JC, Rivera VA, Westen D, Craighead WE, Mayberg HS. Predictors of remission in depression to individual and combined treatments (PReDICT): study protocol for a randomized controlled trial. Trials. 2012 Jul 9;13:106. doi: 10.1186/1745-6215-13-106.

    PMID: 22776534BACKGROUND

  • Dunlop BW, Cha J, Choi KS, Rajendra JK, Nemeroff CB, Craighead WE, Mayberg HS. Shared and Unique Changes in Brain Connectivity Among Depressed Patients After Remission With Pharmacotherapy Versus Psychotherapy. Am J Psychiatry. 2023 Mar 1;180(3):218-229. doi: 10.1176/appi.ajp.21070727. Epub 2023 Jan 18.

    PMID: 36651624DERIVED

  • Brydges CR, Fiehn O, Mayberg HS, Schreiber H, Dehkordi SM, Bhattacharyya S, Cha J, Choi KS, Craighead WE, Krishnan RR, Rush AJ, Dunlop BW, Kaddurah-Daouk R; Mood Disorders Precision Medicine Consortium. Indoxyl sulfate, a gut microbiome-derived uremic toxin, is associated with psychic anxiety and its functional magnetic resonance imaging-based neurologic signature. Sci Rep. 2021 Oct 25;11(1):21011. doi: 10.1038/s41598-021-99845-1.

    PMID: 34697401DERIVED

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

    PMID: 32368793DERIVED

  • Kennedy JC, Dunlop BW, Craighead LW, Nemeroff CB, Mayberg HS, Craighead WE. Follow-up of monotherapy remitters in the PReDICT study: Maintenance treatment outcomes and clinical predictors of recurrence. J Consult Clin Psychol. 2018 Feb;86(2):189-199. doi: 10.1037/ccp0000279.

    PMID: 29369664DERIVED

  • Dunlop BW, Rajendra JK, Craighead WE, Kelley ME, McGrath CL, Choi KS, Kinkead B, Nemeroff CB, Mayberg HS. Functional Connectivity of the Subcallosal Cingulate Cortex And Differential Outcomes to Treatment With Cognitive-Behavioral Therapy or Antidepressant Medication for Major Depressive Disorder. Am J Psychiatry. 2017 Jun 1;174(6):533-545. doi: 10.1176/appi.ajp.2016.16050518. Epub 2017 Mar 24.

    PMID: 28335622DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

EscitalopramDuloxetine HydrochlorideCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThiophenesSulfur CompoundsHeterocyclic Compounds, 1-RingBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Helen Mayberg
Organization
Emory University
hmayber@emory.edu
404-727-6740

Study Officials

  • Helen S. Mayberg, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • W. Edward Craighead, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 4, 2006

Study Start

August 1, 2006

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 30, 2016

Results First Posted

July 28, 2016

Record last verified: 2016-07

Locations

US(2)