Depressive DisorderPhase 4NCT00304161
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
A Phase 4 study testing Atomoxetine in people with Depressive Disorder and Parkinson Disease, run by University of Pennsylvania at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Depressive Disorder, Parkinson Disease
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- IDS score greater than 21
- Mini-Mental State Examination (MMSE) score greater than 15
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Depression Diagnosis and Treatment in Parkinson Disease
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.
Read the detailed description
Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.
- Conditions
- Depressive Disorder, Parkinson Disease
- Being tested
- Atomoxetine, Placebo
- Keywords
- Depression, Parkinson's Disease, Atomoxetine
- Medical subject headings
- Depressive Disorder, Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called Straterra
40 to 80 mg orally once daily for 8 weeks
PlaceboDrug
40 to 80 mg orally once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Active comparator | Participants will receive 40-80mgs of atomoxetine orally once daily. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (1)
Clinical Global Impression-Improvement Scale
The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
A participant scoring a 1 or 2 is considered a responder on the CGI scale.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Daniel Weintraub, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304161
- Sponsor's protocol ID
- K23MH067894
- Other IDs
- K23MH067894
- Status last verified
- Dec 2016
- First submitted
- 15 Mar 2006
- Last updated
- 30 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20679638
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Diagnosis and Treatment in Parkinson Disease
- ClinicalTrials.gov ID
- NCT00304161
- Acronym / sponsor ID
- K23MH067894
- Conditions
- Depressive Disorder, Parkinson Disease
- Keywords
- Depression, Parkinson's Disease, Atomoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 13 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.
Detailed description
Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Active comparator | Drug: AtomoxetineParticipants will receive 40-80mgs of atomoxetine orally once daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's disease
- IDS score greater than 21
- Mini-Mental State Examination (MMSE) score greater than 15
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtomoxetineAlso: Straterra40 to 80 mg orally once daily for 8 weeks | Drug | Atomoxetine |
| Placebo40 to 80 mg orally once daily for 8 weeks | Drug | Placebo |
Primary outcome
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale
Time frame: Week 8
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.
1 secondary outcome
Clinical Global Impression-Improvement Scale
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20679638Weintraub 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.
- ManuscriptLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weintraub, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine in people with Depressive Disorder and Parkinson Disease, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00304161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.