Bipolar I DepressionPhase 2NCT00812058
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
A Phase 2 study testing RG2417 in people with Bipolar I Depression, run by Repligen Corporation at 36 sites in United States.
Trial summary
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Depression
- What is being tested?
- RG2417
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 36 sitesUnited States
- Study dates
- Nov 2008to Dec 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar I Disorder, most recent episode depressed
- History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
Who cannot join
- Current manic, hypomanic or mixed episode
- Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
- Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
- Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
- Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
- Axis II diagnosis likely to interfere with study compliance
Show all 11Show fewer
- Serious suicidal or homicidal risk
- Sensitivity to any of the drug ingredients, including lactose
- Women who are pregnant, breast feeding or refuse to use adequate birth control
- Current seizure disorder
- Current episode of depression is longer than 1 year
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
FutureSearch Trials of Austin
Austin, Texas, 78756
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Northwest Clinical Research Center
Bellevue, Washington, 98004
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226
Massachusetts General Hospital
Boston, Massachusetts, 02114
Unvieristy of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
University of Virginia
Charlottesville, Virginia, 22903
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45408
Duke University Medical Center
Durham, North Carolina, 27710
Valle Vista Health System
Greenwood, Indiana, 46143
University of Texas, Houston Medical Center
Houston, Texas, 77030
Lincoln Research
Lincoln, Rhode Island, 02856
K&S Professional Research Services
Little Rock, Arkansas, 72201
CNS Healthcare
Memphis, Tennessee, 38119
Dean Foundation
Middleton, Wisconsin, 53562
Vanderbilt University School of Medicine
Nashville, Tennessee, 37212
Yale University
New Haven, Connecticut, 06519
Behavioral Clinical Research
North Miami, Florida, 33161
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solution, Inc.
Orlando, Florida, 32806
Western Psychiatric Institute Clinic
Pittsburgh, Pennsylvania, 15213
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210
Richard H. Weisler, MD, PA and Associates
Raleigh, North Carolina, 27609
Mayo Clinic Department of Pscyhiatry & Psychology
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Affiliated Research Institute
San Diego, California, 92108
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
Carman Research
Smyrna, Georgia, 30080
Behavioral Medical Research of States Island
Staten Island, New York, 10305
University of South Florida College of Medicine
Tampa, Florida, 33613
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
- Conditions
- Bipolar I Depression
- Being tested
- RG2417, Placebo
- Keywords
- Bipolar Depression, Bipolar Disease, Bipolar Disorder, Bipolar, Manic Depression, Manic Depressive Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG2417Drug
Also called Uridine
1g bid dose escalates to 2g bid for weeks 2-8.
PlaceboDrug
Also called Sugar Pill
Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
| Study group | Role | What they receive |
|---|---|---|
| RG2417 | Experimental | Oral RG2417 taken twice daily for 8 weeks Receives: Drug: RG2417 |
| Placebo | Placebo comparator | Oral placebo taken twice daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS Score
Measured: Baseline and weekly for 8 weeks
Secondary outcomes (2)
CGI-BP-S
Measured: Baseline and weekly for 8 weeks
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)
Measured: Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DepressionStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repligen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Sachs, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812058
- Sponsor's protocol ID
- RG2417-03
- Status last verified
- Jan 2011
- First submitted
- 18 Dec 2008
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression
- ClinicalTrials.gov ID
- NCT00812058
- Acronym / sponsor ID
- RG2417-03
- Conditions
- Bipolar I Depression
- Keywords
- Bipolar Depression, Bipolar Disease, Bipolar Disorder, Bipolar, Manic Depression, Manic Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Repligen CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Dec 2008 (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.
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RG2417 | Experimental | Drug: RG2417Oral RG2417 taken twice daily for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo taken twice daily for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bipolar I Disorder, most recent episode depressed
- History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
Key exclusion criteria (11 listed)
- Current manic, hypomanic or mixed episode
- Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
- Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
- Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
- Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
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 |
|---|---|---|
| RG2417Also: Uridine1g bid dose escalates to 2g bid for weeks 2-8. | Drug | RG2417 |
| PlaceboAlso: Sugar PillSimilarly sized placebo pills to be taken in the same fashion as the RG2417 tablets. | Drug | Placebo |
Primary outcome
MADRS Score
Time frame: Baseline and weekly for 8 weeks
2 secondary outcomes
CGI-BP-S
Time frame: Baseline and weekly for 8 weeks
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)
Time frame: Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks
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 17 Jan 2011.
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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.
Gary Sachs, MD principal investigator
Massachusetts General Hospital
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RG2417 in people with Bipolar I Depression, run by Repligen Corporation at 36 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 2 inclusion and 11 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 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
MADRS Score (time frame: Baseline and weekly for 8 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 17 Jan 2011.