NCT02268487

Brief Summary

The objective of this project is to assess the occurrence of early improvement within the first two weeks of antidepressant treatment and to correlate this improvement with favorable therapeutic outcome at the end of the acute and treatment continuation phases (8 and 24 weeks, respectively).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Jan 2014

Typical duration for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

October 8, 2014

Last Update Submit

December 10, 2015

Conditions

Major Depressive Disorder

Keywords

Early ImprovementDepressionAntidepressant

Outcome Measures

Primary Outcomes (1)

  • Early Improvement

    20% reduction of baseline score on the Hamilton Depression Scale (HAMD-17)

    2 Weeks

Secondary Outcomes (2)

  • Response

    4 and 8 weeks

  • Remission

    8 and 24 weeks

Study Arms (1)

Sertraline

EXPERIMENTAL

Patients using Sertraline with any dose will be evaluated about Early Improvement

Drug: Sertraline

Interventions

SertralineDRUG

Treatment

Also known as: Early Improvement
Sertraline

Eligibility Criteria

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

You may qualify if:

  • Patients Presenting Depressive Episode according to DSM-IV-TR

You may not qualify if:

  • Patients presenting: psychotic symptoms, Axis 1 comorbidities (except specific phobia, specific social phobia and nicotine dependence) or risk of suicide (defined as score = 3 on item 3 of the 17-item HAMD or at the discretion of rater);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitute of Psychiatry of the University of São Paulo

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (4)

  • Papakostas GI, Perlis RH, Scalia MJ, Petersen TJ, Fava M. A meta-analysis of early sustained response rates between antidepressants and placebo for the treatment of major depressive disorder. J Clin Psychopharmacol. 2006 Feb;26(1):56-60. doi: 10.1097/01.jcp.0000195042.62724.76.

    PMID: 16415707BACKGROUND

  • Thase ME. Methodology to measure onset of action. J Clin Psychiatry. 2001;62 Suppl 15:18-21.

    PMID: 11444762BACKGROUND

  • Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009 Mar;70(3):344-53. doi: 10.4088/jcp.07m03780. Epub 2009 Feb 24.

    PMID: 19254516BACKGROUND

  • Carneiro AM, Pereira DA, Fernandes F, Baptista MN, Brunoni AR, Moreno RA. Distorted thoughts as a mediator of depressive symptoms in patients with major depressive disorder: a longitudinal study. Health Qual Life Outcomes. 2023 Aug 14;21(1):88. doi: 10.1186/s12955-023-02178-y.

    PMID: 37580739DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Moreno A Ricardo, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Fernandes, MD

CONTACT

+55 11 997810107fernandes2000@gmail.com

Moreno A Ricardo, PhD

CONTACT

+55 11 2661 2866gmissio@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fernando Fernandes

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 20, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

BR(1)