NCT00000378

Brief Summary

The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 depression

Timeline
Completed

Started Jul 1997

Typical duration for phase_4 depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
12.9 years until next milestone

Results Posted

Study results publicly available

April 21, 2015

Completed
Last Updated

October 7, 2015

Status Verified

September 1, 2008

Enrollment Period

4.9 years

First QC Date

November 2, 1999

Results QC Date

April 2, 2015

Last Update Submit

October 6, 2015

Conditions

DepressionMelancholia

Keywords

AgedAntidepressive Agents, TricyclicDepressionFemaleHumanMaleMiddle AgeNortriptylineSertralineSerotonin Uptake InhibitorsAntidepressive Agents, Tricyclic -- *therapeutic useAntidepressive Agents, Tricyclic -- adverse effectsDepression -- *drug therapyNortriptyline -- *therapeutic useNortriptyline -- adverse effectsSertraline -- *therapeutic useSertraline -- adverse effectsSerotonin Uptake Inhibitors -- *therapeutic useSerotonin Uptake Inhibitors -- adverse effects

Outcome Measures

Primary Outcomes (1)

  • HAMILTON Rating Scale for DEPRESSION Range

    Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement

    BASELINE COMPARED TO 12 WEEK MEASUREMENT

Study Arms (2)

sertaline

ACTIVE COMPARATOR

patients randomized to sertraline 12 week trial does up to 200mgs

Drug: Sertraline

nortriptyline

ACTIVE COMPARATOR

patients randomized to nortriptyline dose adjusted to therapeutic level

Drug: Nortriptyline

Interventions

SertralineDRUG

12 week trial dose up to 200mgs

sertaline
NortriptylineDRUG

12 week trial dose adjusted to therapeutic level

Also known as: nortiptyline
nortriptyline

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Unipolar major depression (per Diagnostic and Statistical Manuel-IV criteria) with or without melancholia.

You may not qualify if:

  • Patients with the following symptoms or conditions are excluded:
  • Psychotic or atypical subtype of unipolar major depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder

Interventions

SertralineNortriptyline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsDibenzocycloheptenesBenzocycloheptenes

Results Point of Contact

Title
Steven Roose MD
Organization
New York State Psychiatric Institute
spr2@columbia.edu
646-774-8661

Study Officials

  • Steven P. Roose, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

July 1, 1997

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

October 7, 2015

Results First Posted

April 21, 2015

Record last verified: 2008-09

Locations

US(1)