NCT02624102

Brief Summary

Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world. The treatments of choice are the psychotropic drugs of the class of antidepressants and Behavioral or Cognitive Behavior Therapy (CBT). The aim of this study is to compare the efficacy of Trial Based Cognitive Therapy with the Behavioral Activation and pharmacotherapy in the treatment of MDD in a randomized clinical trial witch 96 patients with MDD,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

December 2, 2015

Last Update Submit

March 22, 2022

Conditions

Major Depressive Disorder

Keywords

Major depressive disorderCognitive behavioral therapyTrial based cognitive therapyBehavioral activation

Outcome Measures

Primary Outcomes (1)

  • Severity of Depression

    Change from baseline in severity of depression at twelve weeks. Scale used is Beck Depression Inventory (BDI).

    Twelve weeks (three months)

Secondary Outcomes (9)

  • WHOQoL

    Twelve weeks (three months).

  • WHOQoL

    One year.

  • Cognitive Distortions

    Twelve weeks (Three months).

  • Cognitive Distortions

    One year.

  • Disability

    twelve weeks.

  • +4 more secondary outcomes

Study Arms (3)

Cognitive therapy

EXPERIMENTAL

Major depressive disorder treated with cognitive therapy (Trial Based Cognitive Therapy plus Drug).

Behavioral: Trial based cognitive therapy

Behavioral Therapy

EXPERIMENTAL

Major depressive disorder treated with behavioral therapy (Behavioral Activation plus drug).

Behavioral: Behavioral Activation

Antidepressants

OTHER

Major depressive disorder treated only with antidepressants (Drug alone).

Drug: Antidepressants

Interventions

Trial based cognitive therapyBEHAVIORAL

Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy

Also known as: TBCT
Cognitive therapy
Behavioral ActivationBEHAVIORAL

Patients with MDD, in use of antidepressants plus Behavioral Activation

Also known as: BA
Behavioral Therapy
AntidepressantsDRUG

Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.

Also known as: Pharmacotherapy, Control
Antidepressants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Major Depressive Disorder
  • Both Genres
  • Minimum of 20 in BDI Score
  • Refractory depressive disorder

You may not qualify if:

  • Bipolar disorder
  • High risk of suicide
  • Borderline personality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Curt Hemanny

Salvador, Estado de Bahia, 41815340, Brazil

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Antidepressive AgentsDrug Therapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesTherapeutics

Study Officials

  • Irismar Reis de Oliveira, Ph.D

    Federal University of Bahia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 8, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

April 4, 2022

Record last verified: 2022-03

Locations

BR(1)