BIPOLAR I MOOD DISORDERS
Conditions
Interventions
Trade Name: EBIXA
Pharmaceutical Form: Coated tablet
INN or Proposed INN: MEMANTINE
CAS Number: 19982-08-2
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 30-
Trad
Sponsors
UNIVERSITY OF SASSARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Bipolar Disorder type I (according to DSM-IV TR criteria) 2. Having been in long-term treatment with lithium (plasma levels =0.5 mEq/L) or other mood stabilizers ( Carbamazepine, Valproate or Atypical Antipsychotics, administred at standard daily dose) or their combinations for at least two years at standard therapeutic doses. 3. Showing inadequate response to mood-stabilizers defined by the occurrence of at least two episodes of illness defined by DSM-IV TR criteria and supported by depression (MADRS) and mania (YMRS) ratings, as follows: one or more major depressive episodes with one or more MADRS scores >20; one or more manic/hypomanic episodes with one or more YMRS scores >12; or one or two more mixed episodes with elevated ratings as already defined), and persisting for a total of at least 6 months per year in the previous 24 months of sustained treatment. 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with suspected or known hypersensitivity to the study drugs. 2.Fertile women not taking contraceptives, pregnant or breastfeeding. 3.Patients who have already received the drugs under study within 24 previous months. 4.Patients with clinically significant, active medical illness or abnormal thyroid (TSH) or renal (creatinine) tests. 5.Patients with clinically significant EKG abnormalities. 6. Patients with a history of epileptic seizures or current EEG abnormalities. 7.Patients meeting DSM-IV-TR criteria for a substance-use disorder within the previous 24 months and with currently positive screening assays of urine and blood for commonly abused substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will compare effect of adding, by random selection, memantine or lamotrigine, to the ongoing mood-stabilizer treatment of bipolar disorder patients who have not been adequately stabilized during at least two years of adequate trials of standard mood-stabilizers: lithium, anticonvulsants, or modern antipsychotics, alone or in various combinations. Ongoing mood-stabilizer treatments will be held constant during the proposed one-year trial. Lamotrigine is selected as the study comparator since it is the only anticonvulsant medication approved by the US Food and Drug Administration for long-term prevention of recurrences of all phases of bipolar I disorder. ;Secondary Objective: NOT APPLICABLE;Primary end point(s): Primary endpoints (within 52 weeks): 1. Reduction from the previous 24 months of the number and total weeks of manic/hypomanic, depressive or mixed recurrences, based on clinical assessments to ascertain DSM-IV-TR diagnostic criteria, as well as use of averaged ratings (up to 52/patient) of YMRS, MADRS, and CGIBP (CGI-BP-Severity, CGI-BP-Improvement) scores. 2. Latency (weeks) from the start of experimental treatment to emergence of a first new episode (recurrence) of illness. ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional data to be considered include: sex, age, marital status, educational level and occupation, as well as diagnosis, age at onset, polarity of first-lifetime episode, illness duration, total number of episodes and their polarity per year of illness, and psychiatric family history. Secondary endpoints will include the total and average mg/day doses of each psychotropic agent employed during the one-year protocol. ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Italy
Contacts
Public ContactGINO SERRA
UNIVERSITY OF SASSARI
Outcome results
None listed