Clinical trial NCT01674010: Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bipolar 1 Disorder
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2012-08-28
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: up to 48 weeks
Secondary outcomes:
measure: Proportion of Study Participants With Recurrence of Any Mood Episode
timeFrame: up to 48 weeks
measure: Time to Recurrence of a Depressive Episode
timeFrame: up to 48 weeks
measure: Time to Recurrence of a Manic/Hypomanic or a Mixed Episode
timeFrame: up to 48 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Elan Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Elan Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Elan Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Elan Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Elan Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Elan Investigational Site
state: California
city: Costa Mesa
country: United States
facility: Elan Investigational Site
state: California
city: Escondido
country: United States
facility: Elan Investigational Site
state: California
city: Garden Grove
country: United States
facility: Elan Investigational Site
state: California
city: National City
country: United States
facility: Elan Investigational Site
state: California
city: Oceanside
country: United States
facility: Elan Investigational Site
state: California
city: Palo Alto
country: United States
facility: Elan Investigational Site
state: California
city: Riverside
country: United States
facility: Elan Investigational Site
state: California
city: San Diego
country: United States
facility: Elan Investigational Site
state: California
city: Santa Ana
country: United States
facility: Elan Investigational Site
state: California
city: Stanford
country: United States
facility: Elan Investigational Site
state: California
city: Norwich
country: United States
facility: Elan Investigational Site
state: Connecticut
city: North Miami
country: United States
facility: Elan Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Elan Investigational Site
state: Florida
city: Tampa
country: United States
facility: Elan Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Elan Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Elan Investigational Site
state: Georgia
city: Creve Coeur
country: United States
facility: Elan Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Elan Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Elan Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Elan Investigational Site
state: Nebraska
city: Marlton
country: United States
facility: Elan Investigational Site
state: New Jersey
city: Fresh Meadows
country: United States
facility: Elan Investigational Site
state: New York
city: New York
country: United States
facility: Elan Investigational Site
state: New York
city: Raleigh
country: United States
facility: Elan Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Elan Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Elan Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Elan Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Elan Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Elan Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Elan Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Elan Investigational Site
state: Texas
city: Hurst
country: United States
facility: Elan Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Elan Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Elan Investigational Site
state: Utah
city: Bellevue
country: United States
facility: Elan Investigational Site
state: Washington
city: Kardzhali
country: Bulgaria
facility: Elan Investigational Site
city: Pazardzhik
country: Bulgaria
facility: Elan Investigational Site
city: Sofia
country: Bulgaria
facility: Elan Investigational Site
city: Sofia
country: Bulgaria
facility: Elan Investigational Site
city: Varna
country: Bulgaria
facility: Elan Investigational Site
city: Vratsa
country: Bulgaria
facility: Elan Investigational Site
city: Edmonton
country: Canada
facility: Elan Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Elan Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Elan Investigational Site
state: Nova Scotia
city: Chatham
country: Canada
facility: Elan Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Elan Investigational Site
state: Ontario
city: London
country: Canada
facility: Elan Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Elan Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Elan Investigational Site
state: Ontario
city: Praha
country: Czechia
facility: Elan Investigational Site
city: Praha
country: Czechia
facility: Elan Investigational Site
city: Praha
country: Czechia
facility: Elan Investigational Site
city: Praha
country: Czechia
facility: Elan Investigational Site
city: Strakonice
country: Czechia
facility: Elan Investigational Site
city: Bully-Les-Mines
country: France
facility: Elan Investigational Site
city: Dole
country: France
facility: Elan Investigational Site
city: Elancourt
country: France
facility: Elan Investigational Site
city: Nimes
country: France
facility: Elan Investigational Site
city: Toulouse
country: France
facility: Elan Investigational Site
city: Toulouse
country: France
facility: Elan Investigational Site
city: Bydgoszcz
country: Poland
facility: Elan Investigational Site
city: Gdansk
country: Poland
facility: Elan Investigational Site
city: Lodz
country: Poland
facility: Elan Investigational Site
city: Tuszyn
country: Poland
facility: Elan Investigational Site
city: Brasov
country: Romania
facility: Elan Investigational Site
city: Bucharest
country: Romania
facility: Elan Investigational Site
city: Craiova
country: Romania
facility: Elan Investigational Site
city: Sibiu
country: Romania
facility: Elan Investigational Site
city: Torrevieja
country: Spain
facility: Elan Investigational Site
state: Alicante
city: Oviedo
country: Spain
facility: Elan Investigational Site
state: Asturias
city: Barcelona
country: Spain
facility: Elan Investigational Site
city: Vitoria
country: Spain
facility: Elan Investigational Site
city: Ankara
country: Turkey
facility: Elan Investigational Site
city: Diyarbakir
country: Turkey
facility: Elan Investigational Site
city: Edirne
country: Turkey
facility: Elan Investigational Site
city: Istanbul
country: Turkey
facility: Elan Investigational Site
Study officials:
References: