A 6-WEEK STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM ORDIVALPROEX FOR THE TREATMENT OF BIPOLARDEPRESSION IN SUBJECTS NOT RESPONDING TO TREATMENT WITH LITHIUM OR DIVALPROEX ALONE

• Conditions: Bipolar disorder; MedDRA version: 14.0Level: LLTClassification code 10004936Term: Bipolar depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-019778-34-LT
• Lead Sponsor: Sunovion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-15
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Subjects 18 to 75 years of age inclusive, with bipolar I disorder, most recent episode depressed with or without rapid cycling disease course (= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-IV-TR criteria, and confirmed by the MINI). The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
• Subjects must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member, caregiver, or treating health professional), be available to confirm this history.
• Subject’s current major depressive episode is = 4 weeks and less than 12 months in duration.
• MADRS total score = 20 (at both screening and baseline visits)
• YMRS total score = 12 (at both screening and baseline visits)
• Subjects requiring prospective run-in treatment and subjects meeting randomization criteria at the time of screening must be appropriate candidates for lithium or divalproex treatment, in the judgment of the investigator. All subjects are required to have had a minimum of 28 days of treatment with lithium or divalproex and will be required to demonstrate serum levels within the protocol-specified therapeutic range at least once during the 28 days of treatment prior to randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340
;
• Subjects 18 to 75 years of age inclusive, with bipolar I disorder, most recent episode depressed with or without rapid cycling disease course (= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) and without psychotic features (diagnosed by DSM-IV-TR criteria, and confirmed by the MINI). The current episode of major depression associated with bipolar I disorder must be confirmed by the investigator and noted in the source records.
• Subjects must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member, caregiver, or treating health professional), be available to confirm this history.
• Subject’s current major depressive episode is = 4 weeks and less than 12 months in duration.
• MADRS total score = 20 (at both screening and baseline visits)
• YMRS total score = 12 (at both screening and baseline visits)
• Subjects requiring prospective run-in treatment and subjects meeting randomization criteria at the time of screening must be appropriate candidates for lithium or divalproex treatment, in the judgment of the investigator. All subjects are required to have had a minimum of 28 days of treatment with lithium or divalproex and will be required to demonstrate serum levels within the protocol-specified therapeutic range at least once during the 28 days of treatment prior to randomization.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

• Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months prior to screening
• Subject scores = 4 on MADRS item number 10 (suicidal thoughts) at screening or baseline
• History of non-response to an adequate (6-week) monotherapy trial of three or more antidepressants administered within the package-defined therapeutic dose-range (with or without mood stabilizers) during the current episode
• Imminent risk of suicide or injury to self, others, or property

;
• Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months prior to screening
• Subject scores = 4 on MADRS item number 10 (suicidal thoughts) at screening or baseline
• History of non-response to an adequate (6-week) monotherapy trial of three or more antidepressants administered within the package-defined therapeutic dose-range (with or without mood stabilizers) during the current episode
• Imminent risk of suicide or injury to self, others, or property

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified