NCT00304161

Brief Summary

This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 13, 2015

Completed
Last Updated

January 30, 2017

Status Verified

December 1, 2016

Enrollment Period

4.4 years

First QC Date

March 15, 2006

Results QC Date

June 12, 2012

Last Update Submit

December 1, 2016

Conditions

Depressive DisorderParkinson Disease

Keywords

DepressionParkinson's DiseaseAtomoxetine

Outcome Measures

Primary Outcomes (1)

  • Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale

    The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a \>50% decrease in IDS-C score from baseline.

    Week 8

Secondary Outcomes (1)

  • Clinical Global Impression-Improvement Scale

    Week 8

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

Participants will receive 40-80mgs of atomoxetine orally once daily.

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.

Drug: Placebo

Interventions

AtomoxetineDRUG

40 to 80 mg orally once daily for 8 weeks

Also known as: Straterra
Atomoxetine
PlaceboDRUG

40 to 80 mg orally once daily for 8 weeks

Placebo

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic Parkinson's disease
  • IDS score greater than 21
  • Mini-Mental State Examination (MMSE) score greater than 15

You may not qualify if:

  • Recent deep brain stimulation
  • Currently participating in an antidepressant trial at a less than adequate dose and duration
  • Severe depression or depression with suicide ideation
  • History of liver toxicity
  • Unstable medical disease or comorbid psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Weintraub D, Mavandadi S, Mamikonyan E, Siderowf AD, Duda JE, Hurtig HI, Colcher A, Horn SS, Nazem S, Ten Have TR, Stern MB. Atomoxetine for depression and other neuropsychiatric symptoms in Parkinson disease. Neurology. 2010 Aug 3;75(5):448-55. doi: 10.1212/WNL.0b013e3181ebdd79.

    PMID: 20679638RESULT

Related Links

MeSH Terms

Conditions

Depressive DisorderParkinson DiseaseDepression

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Limitations and Caveats

First, the sample size was relatively small. Second, the diagnostic criteria for depression which are typically used in clinical trials were not used as an inclusion criterion. Third, antidepressant use at baseline was common in our population.

Results Point of Contact

Title
Dr. Daniel Weintraub
Organization
University of Pennsylvania
daniel.weintraub@uphs.upenn.edu
215-349-8207

Study Officials

  • Daniel Weintraub, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

July 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 30, 2017

Results First Posted

March 13, 2015

Record last verified: 2016-12

Locations

US(2)