Bipolar DepressionPhase 2NCT00322764
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
A Phase 2 study testing Uridine in people with Bipolar Depression, run by Repligen Corporation at 11 sites in United States.
Trial summary
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Uridine
- How many people
- 80 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2006to not given
- 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
- Adult, Older adult
Who may be able to join
- DSM-IV-TR diagnosis of Bipolar I Depression
- 18 to 65 years of age, inclusive
- Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
- Duration of current depressive episode of at least four weeks by Day 1
- Competent to give informed consent
Who cannot join
- Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of > 12 at Screening and/or Day 1
- Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
- A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
- Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
- An Axis II diagnosis that is likely to interfere with protocol compliance
- Initiation of or increase in psychotherapy within 4 weeks of Screening
Show all 18Show fewer
- Psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on Day 1; fluoxetine within 2 weeks of initiation of study drug on Day 1
- Serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the MADRS at Screening and/or Day 1
- History of sensitivity to any of the ingredients in the study drug
- Clinically significant abnormality in any screening laboratory results
- Clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
- Women who are pregnant, breastfeeding, or refuse to use adequate birth control
- Current seizure disorder
- Participation in an investigational drug study within twenty-eight days of Day 1
- Current psychotic episode
- Clozaril use and/or electroconvulsive therapy within six months of Day 1
- Failure of three or more adequate trials of standard therapies for depression during the current episode
- Current episode of depression is longer than one year
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Future Search Trials of Austin
Austin, Texas, 78756
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Future Search Trials of Dallas
Dallas, Texas, 75231
Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, 46202
Medical & Behavioral Health Research, PC
New York, New York, 10023
Marc Hertzman, MD, PC
Rockville, Maryland, 20852
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Carman Research
Smyrna, Georgia, 30080
Stanford University
Stanford, California, 94305
About this study
Official title: Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
- Conditions
- Bipolar Depression
- Being tested
- Uridine
- Keywords
- manic depression, bipolar disorder, depression, uridine, RG2417
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UridineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 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
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Repligen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Jacoby, MD, PhD, Study director, Repligen Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322764
- Sponsor's protocol ID
- RG2417-01
- Status last verified
- Nov 2007
- First submitted
- 4 May 2006
- Last updated
- 9 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression
- ClinicalTrials.gov ID
- NCT00322764
- Acronym / sponsor ID
- RG2417-01
- Conditions
- Bipolar Depression
- Keywords
- manic depression, bipolar disorder, depression, uridine, RG2417
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Repligen CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 8 May 2006 (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 primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV-TR diagnosis of Bipolar I Depression
- 18 to 65 years of age, inclusive
- Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
- Duration of current depressive episode of at least four weeks by Day 1
- Competent to give informed consent
Key exclusion criteria (18 listed)
- Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of > 12 at Screening and/or Day 1
- Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
- A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
- Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
- An Axis II diagnosis that is likely to interfere with protocol compliance
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 |
|---|---|---|
| Uridine | Drug | – |
Primary outcome
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
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 9 Nov 2007.
Related trials for Bipolar Depression
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
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.
David Jacoby, MD, PhD study director
Repligen Corporation
11 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 Uridine in people with Bipolar Depression, run by Repligen Corporation at 11 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 5 inclusion and 18 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 9 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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?
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo. 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 9 Nov 2007.