Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OPKO Health, Inc.
With
Elan Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit.
Has a history in the last 3 years of ≥ 1 manic or mixed episodes of sufficient severity that required hospitalization and/or treatment with a mood stabilizer or antipsychotic, or confirmed by a family member or medical records to ensure the episode fulfills the DSM-IV-TR criteria.
Has experienced a mood episode of any polarity within 4 months prior to the Screening Visit and responded to StOC therapy.
Is euthymic at the Screening Visit (ie, score of ≤ 12 on the MADRS and a score of ≤ 12 on the Y-MRS).
Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made for tolerability reasons will be acceptable.
A study patient must meet the following additional criteria to be eligible for randomization in the Double-blind Randomization Phase of this study:
\- Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores of ≤ 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be allowed throughout Phase 1. Excursions are defined as Y-MRS or MADRS scores \>12 but ≤ 16.
You may not be if
Woman of childbearing potential who is unwilling or unable to use an acceptable method of birth control or is using a prohibited contraceptive method.
Is found to be actively suicidal on the C-SSRS (answer of "yes" to question 4 or 5 \[current or over the last 30 days\]) or a score of ≥4 on the MADRS item 10 at the Screening Visit.
Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone (TSH) \>3 mIU/L at the Screening Visit.
Has received electroconvulsive therapy (ECT) during the current episode or within 6 months prior to the Screening Visit.
Has an estimated glomerular filtration rate \<40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula.
A study patient who meets ANY of the above and ANY of the criteria below will not be eligible for enrollment in the Double-blind Randomization Phase of this study:
Has current signs or symptoms of psychosis.
Has become actively suicidal as defined by C-SSRS answer of "yes" to question 4 or 5 (current or over the last 30 days) and/or has a score of ≥4 on MADRS item 10.
Clareo Health | Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
