DepressionPhase 4NCT00231959
Effectiveness of Pramipexole for Treatment-Resistant Depression
A Phase 4 study testing Pramipexole (Mirapex) in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Pramipexole (Mirapex)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for major depressive disorder
- Meets criteria for current major depressive episode
- Score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) at the baseline visit
- Currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
- Agrees to use an effective form of contraception throughout the study
Who cannot join
- Pregnant
- At risk for suicide or homicide
- Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
- History of a substance use disorder within 6 months of study enrollment
- History of or current psychotic features
- Currently being treated with typical or atypical antipsychotic medications
Show all 15Show fewer
- Currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
- Clinical or laboratory evidence of untreated hypothyroidism
- History of a 2-week or longer course of pramipexole
- Intolerance of pramipexole at any dose
- Any investigational psychotropic drug use within the last three months
- Level 3 or greater antidepressant resistance as assessed by the ATHF
- Three or more episodes of self-harm in the year prior to study enrollment
- Documented history of poor treatment adherence or frequently missed appointments
- Parkinson's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Double-Blind Placebo-Controlled Trial of Adjunctive Pramipexole, a Dopamine Receptor Agonist, for Treatment Resistant Major Depressive Episodes
This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.
Read the detailed description
Depression is a serious medical illness, for which various types of treatment have been developed. Both medications and therapies have proven effective in treating depression. However, some people with depression do not benefit from these treatments. New medications are needed for treating depression in those who have not responded to commonly used antidepressants. Pramipexole (Mirapex) is most often used for the treatment of Parkinson's disease, but has been reported to have antidepressant effects as well. This study will evaluate the effectiveness of pramipexole in treating depression in individuals that have not responded to other medications.
Participants in this double blind study will be randomly assigned to receive either pramipexole or placebo, in addition to their current medications, for 8 weeks. Treatment response will be assessed at the end of this phase by measuring symptoms of depression. At this time, those individuals who have responded to treatment will have the option to continue in a 6-month follow-up study. Participants will be seen monthly throughout the 6 months to assess treatment response. Participants who do not exhibit a response to treatment will be tapered off the medication. All participants will receive 3 months of follow-up care, regardless of their response to the medication.
- Conditions
- Depression
- Being tested
- Pramipexole (Mirapex), Placebo
- Keywords
- Depression, Treatment-Resistant
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole (Mirapex)Drug
pramipexole 0.5mg tablets qd and titrated per protocol
PlaceboDrug
sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Placebo Receives: Drug: Placebo |
| Pramipexole | Experimental | Not described Receives: Drug: Pramipexole (Mirapex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Montgomery-Asberg Depression Rating Scale
Measured: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders
Clinical Global Impressions (CGI) scale
Measured: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2003
- Primary completionSep 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Roy Perlis, Massachusetts General Hospital
- Investigators
- Roy Perlis, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231959
- Sponsor's protocol ID
- K23MH067060
- Other IDs
- K23MH067060, DATR AK-TNGP1
- Status last verified
- Apr 2012
- First submitted
- 30 Sep 2005
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cusin C, Iovieno N, Iosifescu DV, Nierenberg AA, Fava M, Rush AJ, Perlis RH. A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder. J Clin Psychiatry. 2013 Jul;74(7):e636-41. doi: 10.4088/JCP.12m08093.
PubMed 23945458
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Trial of Adjunctive Pramipexole, a Dopamine Receptor Agonist, for Treatment Resistant Major Depressive Episodes
- ClinicalTrials.gov ID
- NCT00231959
- Acronym / sponsor ID
- K23MH067060
- Conditions
- Depression
- Keywords
- Depression, Treatment-Resistant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
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 pramipexole (Mirapex) in managing treatment-resistant depression.
Detailed description
Depression is a serious medical illness, for which various types of treatment have been developed. Both medications and therapies have proven effective in treating depression. However, some people with depression do not benefit from these treatments. New medications are needed for treating depression in those who have not responded to commonly used antidepressants. Pramipexole (Mirapex) is most often used for the treatment of Parkinson's disease, but has been reported to have antidepressant effects as well. This study will evaluate the effectiveness of pramipexole in treating depression in individuals that have not responded to other medications.
Participants in this double blind study will be randomly assigned to receive either pramipexole or placebo, in addition to their current medications, for 8 weeks. Treatment response will be assessed at the end of this phase by measuring symptoms of depression. At this time, those individuals who have responded to treatment will have the option to continue in a 6-month follow-up study. Participants will be seen monthly throughout the 6 months to assess treatment response. Participants who do not exhibit a response to treatment will be tapered off the medication. All participants will receive 3 months of follow-up care, regardless of their response to the medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: PlaceboPlacebo |
| Pramipexole | Experimental | Drug: Pramipexole (Mirapex) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets diagnostic criteria for major depressive disorder
- Meets criteria for current major depressive episode
- Score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) at the baseline visit
- Currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
- Agrees to use an effective form of contraception throughout the study
Key exclusion criteria (15 listed)
- Pregnant
- At risk for suicide or homicide
- Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
- History of a substance use disorder within 6 months of study enrollment
- History of or current psychotic features
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 |
|---|---|---|
| Pramipexole (Mirapex)pramipexole 0.5mg tablets qd and titrated per protocol | Drug | Pramipexole |
| Placebosugar pill | Drug | Sugar pill |
Primary outcome
Score on the Montgomery-Asberg Depression Rating Scale
Time frame: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders
Clinical Global Impressions (CGI) scale
Time frame: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
- Derived from this study: PubMed 23945458Cusin C, Iovieno N, Iosifescu DV, Nierenberg AA, Fava M, Rush AJ, Perlis RH. A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder. J Clin Psychiatry. 2013 Jul;74(7):e636-41. doi: 10.4088/JCP.12m08093.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Roy Perlis, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pramipexole (Mirapex) in people with Depression, run by Massachusetts General Hospital 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 5 inclusion and 15 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 26 Apr 2012. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score on the Montgomery-Asberg Depression Rating Scale (time frame: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders). The study lists 2 primary outcomes in all. 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 NCT00231959, 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 26 Apr 2012.