NCT00178035

Brief Summary

This study will determine the effectiveness of total sleep deprivation (TSD) for one night plus paroxetine versus either TSD plus placebo or paroxetine alone in inducing rapid symptom resolution of major depression in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for phase_4 depression

Timeline
Completed

Started Dec 1999

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

December 1, 1999

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.1 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
Last Updated

August 2, 2013

Status Verified

July 1, 2013

First QC Date

September 13, 2005

Last Update Submit

July 31, 2013

Conditions

Depression

Keywords

DepressionUnipolar DepressionElderly depressionLate-Life

Outcome Measures

Primary Outcomes (1)

  • Combined treatment of total sleep deprivation(TSD)for one night + paroxetine will be superior to the combination of placebo + TSD and to paroxetine alone (without TSD)in bringing about rapid resolution of depressive symptoms.

Secondary Outcomes (6)

  • EEG Sleep measures

  • Cognitive status: Folstein Mini-Mental Status Exam, and CDR

  • Quality of Life measures: Quality of Wellbeing Scale, CIDI Health Services Utilization, OARS, GAF, PSQI, SF-36, UKU, and CIRS-G

  • Social Support: Interpersonal Support Evaluation List, Luben Social Network Scale

  • Psychiatric status: SCID, Hamilton Depression Rating Scale, Suicidal History Questionnaire, Antidepressant Treatment History Form, Brief Psychiatric Rating Scale, and anxiety subscale of Brief Symptom Inventory

  • +1 more secondary outcomes

Interventions

paroxetineDRUG
One night of Total Sleep DeprivationBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Age 60 and older
  • Current episode of unipolar, major depression
  • HRSD (17 item)score of 15 or higher
  • Folstein Mini-Mental Status exam score of 17 or higher

You may not qualify if:

  • Lifetime diagnosis of any psychotic disorder
  • Lifetime diagnosis of bipolar disorder
  • \_Alcohol or drug abuse within the past 6 months
  • Contraindication to treatment with SSRI therapy
  • History of seizure disorder
  • Baseline apnea/hypopnea index of 20 or higher
  • Hyponatremia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Charles F Reynolds III, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

December 1, 1999

Study Completion

August 1, 2003

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

US(1)