NCT00057577

Brief Summary

This study will determine whether the addition of Cognitive Therapy (CT) to antidepressant medication (ADM) enhances treatment for depression. This study will also test whether the addition of CT to ADM will prevent recurrences of depression after therapy is over.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
452

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4 depression

Geographic Reach
1 country

3 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

October 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 2, 2015

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

9.8 years

First QC Date

April 4, 2003

Results QC Date

December 18, 2013

Last Update Submit

May 22, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

  • Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)

    Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)

    Through month 18 of treatment

  • Number of Participants in Recovery According to the LIFE and HRSD

    Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)

    Through 36 months of treatment

  • Number of Participants in Recurrence According to the LIFE and HRSD

    Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)

    Measured up to Month 36 from recovery

Other Outcomes (1)

  • Serious Adverse Events

    Throughout study, up to 54 months

Study Arms (2)

Cognitive therapy plus medications

EXPERIMENTAL

Participants will receive antidepressant medication plus cognitive therapy

Behavioral: Cognitive TherapyDrug: Medications

Medications alone

EXPERIMENTAL

Participants will receive maintenance of antidepressant medication alone

Drug: Medications

Interventions

Cognitive TherapyBEHAVIORAL

CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.

Also known as: CT
Cognitive therapy plus medications
MedicationsDRUG

Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms.

Also known as: ADM
Cognitive therapy plus medicationsMedications alone

Eligibility Criteria

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

You may qualify if:

  • Recurrent or chronic major depressive disorder

You may not qualify if:

  • Current diagnosis of psychotic affective disorder
  • History of nonaffective psychotic disorder
  • Substance dependence last three months requiring detox
  • Schizotypal, antisocial, or borderline personality disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rush Medical Center - Treatment Research Unit

Chicago, Illinois, 60612, United States

Location

Depression Research Unit, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Adult Outpatient Psychiatry

Nashville, Tennessee, 37203, United States

Location

Related Publications (4)

  • Khazanov GK, Xu C, Hollon SD, DeRubeis RJ, Thase ME. Adding cognitive therapy to antidepressant medications decreases suicidal ideation. J Affect Disord. 2021 Feb 15;281:183-191. doi: 10.1016/j.jad.2020.12.032. Epub 2020 Dec 8.

    PMID: 33326891DERIVED

  • Khazanov GK, Xu C, Dunn BD, Cohen ZD, DeRubeis RJ, Hollon SD. Distress and anhedonia as predictors of depression treatment outcome: A secondary analysis of a randomized clinical trial. Behav Res Ther. 2020 Feb;125:103507. doi: 10.1016/j.brat.2019.103507. Epub 2019 Oct 31.

    PMID: 31896529DERIVED

  • DeRubeis RJ, Zajecka J, Shelton RC, Amsterdam JD, Fawcett J, Xu C, Young PR, Gallop R, Hollon SD. Prevention of Recurrence After Recovery From a Major Depressive Episode With Antidepressant Medication Alone or in Combination With Cognitive Behavioral Therapy: Phase 2 of a 2-Phase Randomized Clinical Trial. JAMA Psychiatry. 2020 Mar 1;77(3):237-245. doi: 10.1001/jamapsychiatry.2019.3900.

    PMID: 31799993DERIVED

  • Hollon SD, DeRubeis RJ, Fawcett J, Amsterdam JD, Shelton RC, Zajecka J, Young PR, Gallop R. Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1157-64. doi: 10.1001/jamapsychiatry.2014.1054.

    PMID: 25142196DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral TherapyDosage Forms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Results Point of Contact

Title
Dr. Steven D. Hollon
Organization
Vanderbilt University
steven.d.hollon@vanderbilt.edu
615-322-3369

Study Officials

  • Steven D. Hollon, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Robert J. DeRubeis, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Jan A. Fawcett, MD

    Rush Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

April 4, 2003

First Posted

April 7, 2003

Study Start

October 1, 2002

Primary Completion

July 1, 2012

Study Completion

March 1, 2014

Last Updated

May 30, 2017

Results First Posted

April 2, 2015

Record last verified: 2017-05

Locations

US(3)