NCT00177996

Brief Summary

This research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_4

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

October 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

5.3 years

First QC Date

September 13, 2005

Last Update Submit

January 14, 2016

Conditions

Major Depression

Keywords

depressionanxiety

Outcome Measures

Primary Outcomes (1)

  • Somatic Symptoms Scale (SSC)

    Scale to evaluate somatic and panic like symptoms

    1 week

Secondary Outcomes (2)

  • Hamilton Rating Scale For Depression- 25 item (HRSD 25)

    1 week

  • Global Assessment of Functioning (GAF)

    past week

Study Arms (2)

Sertaline high dose titration

ACTIVE COMPARATOR

The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline high dose titration) are consistent with recommended FDA guidelines.

Drug: sertraline hydrochloride

Sertaline low dose titration

ACTIVE COMPARATOR

The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of Sertraline hydrochloride. The doses and titration schedules used in this arm (Sertaline low dose titration) are consistent with recommended FDA guidelines.

Drug: sertraline hydrochloride

Interventions

sertraline hydrochlorideDRUG

The study was a double-blind study in which subjects diagnosed with major depression complicated by lifetime panic spectrum symptomatology were randomized to either high (but still within the standards of normal clinical practice) or low dose titration schedules of sertraline. The doses and titration schedules used in this study are consistent with recommended FDA guidelines.

Also known as: sertraline hydrochloride low versus high dose titration
Sertaline high dose titrationSertaline low dose titration

Eligibility Criteria

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

You may qualify if:

  • Male or female ages 18-60;
  • Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
  • Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
  • Physically healthy,
  • Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;

You may not qualify if:

  • Females who are pregnant or breast-feeding;
  • History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
  • History of hypersensitivity to or current use of sertraline;
  • Unstable or untreated medical conditions,
  • Participants who do not wish to discontinue current, ineffective antidepressant treatment;
  • Participants who have recently begun psychotherapy (less than 3 months prior to study entry);
  • Diagnosis of current panic disorder, psychosis, substance or alcohol abuse, anorexia, bulimia, dissociative, bipolar disorder, or any other psychiatric or medical illness that would interfere with the best treatment strategy for the potential participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Insititue and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionAnxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Andrea Fagiolini, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 2001

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(1)