Parkinson's DiseasePhase 2/3NCT00070941
SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
A Phase 2/3 study testing SAM-e and oral escitalopram in people with Parkinson's Disease and Depression, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease, Depression
- What is being tested?
- SAM-e and oral escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Oct 2010
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment
- Stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry
- No antidepressant or antipsychotic medications within 30 days prior to study entry
- Agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial
- Acceptable methods of contraception
- Ability to read and/or follow written and oral instructions presented in English
- Sufficient cognitive ability (baseline Mini-Mental Status > 24) to provide informed consent
Who cannot join
- History of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials
- Certain abnormal laboratory values
- Pregnant or breastfeeding
- Use of an investigational drug within 3 months of study entry
- Use of St. John's Wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry
- Selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry
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- Regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed
- Psychotherapy initiated in the 6 months prior to study entry
- History of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder
- Serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential
- Use of dopamine receptor antagonist (metoclopramide, haloperidol)
- Secondary Parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAM-e Treatment of Depression in Parkinson's Disease.
This study will test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).
Read the detailed description
PD is commonly associated with depression, but conventional antidepressants have limited efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the United States as a food supplement and is promoted as a mood enhancer. SAM-e improves dopamine transmission, may have a beneficial effect on dopamine receptors, and may be a good alternative to the currently-used antidepressants in patients with PD. This study will investigate whether SAM-e is safe and effective in the treatment of depression associated with PD. The efficacy of SAM-e will be compared to placebo and to escitalopram, a selective serotonin reuptake inhibitor commonly used for the treatment of depression in PD.
Participants in this study will be randomly assigned to receive SAM-e, escitalopram, or placebo for 12 weeks. Some participants may choose to extend treatment for an additional 12 weeks (for a total of 24 weeks on study medication). Participants will have study visits at entry and Weeks 2, 4, 8, and 12. Study visits will include neurological evaluation, psychiatric evaluation, blood tests, and quality of life questionnaires. A telephone interview will be conducted at Week 10.
- Conditions
- Parkinson's Disease, Depression
- Being tested
- SAM-e, oral escitalopram, placebo
- Keywords
- Parkinsons Disease, Depression, SAM-e
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM-eDrug
Also called 1 Experimental
oral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram.
oral escitalopramDrug
20mg or 30mg daily in two divided doses, along with placebo SAM-e.
placeboDrug
oral placebo escitalopram and oral placebo SAM-e daily in two divided doses.
| Study group | Role | What they receive |
|---|---|---|
| SAM-e | Experimental | 40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram. Receives: Drug: SAM-e |
| Escitalopram | Active comparator | 40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e. Receives: Drug: oral escitalopram |
| Placebo Comparator | Placebo comparator | 20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Scale
very severe, >23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startJul 2003
- Primary completionJun 2010
- Study completionOct 2010
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.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Alessandro Di Rocco, MD, Principal investigator, NYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070941
- Sponsor's protocol ID
- R01AT000941-01A1
- Other IDs
- R01AT000941-01A1, 075255364
- Status last verified
- Jun 2016
- First submitted
- 9 Oct 2003
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAM-e Treatment of Depression in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00070941
- Acronym / sponsor ID
- R01AT000941-01A1
- Conditions
- Parkinson's Disease, Depression
- Keywords
- Parkinsons Disease, Depression, SAM-e
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Study start
- Jul 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Oct 2003 (estimated)
- Results
- Posted 13 Jul 2016
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 test a chemical called s-adenosyl-methionine (SAM-e) for the treatment of depression in patients with Parkinson's disease (PD).
Detailed description
PD is commonly associated with depression, but conventional antidepressants have limited efficacy in patients with PD and may exacerbate motor symptoms. SAM-e is available in the United States as a food supplement and is promoted as a mood enhancer. SAM-e improves dopamine transmission, may have a beneficial effect on dopamine receptors, and may be a good alternative to the currently-used antidepressants in patients with PD. This study will investigate whether SAM-e is safe and effective in the treatment of depression associated with PD. The efficacy of SAM-e will be compared to placebo and to escitalopram, a selective serotonin reuptake inhibitor commonly used for the treatment of depression in PD.
Participants in this study will be randomly assigned to receive SAM-e, escitalopram, or placebo for 12 weeks. Some participants may choose to extend treatment for an additional 12 weeks (for a total of 24 weeks on study medication). Participants will have study visits at entry and Weeks 2, 4, 8, and 12. Study visits will include neurological evaluation, psychiatric evaluation, blood tests, and quality of life questionnaires. A telephone interview will be conducted at Week 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAM-e | Experimental | Drug: SAM-e40 subjects receiving oral SAM-e, 1200mg or 1800mg daily in two divided doses, and placebo escitalopram. |
| Escitalopram | Active comparator | Drug: oral escitalopram40 subjects receiving oral escitalopram 20mg or 40 mg daily, in two divided doses, and placebo SAM-e. |
| Placebo Comparator | Placebo comparator | Drug: placebo20 subjects receiving oral placebo escitalopram and placebo SAM-3 daily in two divided doses. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Idiopathic Parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment
- Stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry
- No antidepressant or antipsychotic medications within 30 days prior to study entry
- Agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial
- Acceptable methods of contraception
Key exclusion criteria (12 listed)
- History of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials
- Certain abnormal laboratory values
- Pregnant or breastfeeding
- Use of an investigational drug within 3 months of study entry
- Use of St. John's Wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry
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 |
|---|---|---|
| SAM-eAlso: 1 Experimentaloral SAM-e in two divided doses, 1200mg or 1800mg daily, with placebo escitalopram. | Drug | SAM-e |
| oral escitalopram20mg or 30mg daily in two divided doses, along with placebo SAM-e. | Drug | Escitalopram |
| placebooral placebo escitalopram and oral placebo SAM-e daily in two divided doses. | Drug | Placebo Comparator |
Primary outcome
Change in Hamilton Depression Scale
Time frame: 12 weeks
very severe, >23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alessandro Di Rocco, MD principal investigator
NYU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SAM-e and oral escitalopram in people with Parkinson's Disease and Depression, run by NYU Langone Health at 1 site 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 7 inclusion and 12 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jul 2016). 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?
Change in Hamilton Depression Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2016.