Memantine and Cognitive Dysfunction in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Cognitive Dysfunction
Intervention: Memantine; Placebo
Intervention description: Week 0: 5 mg memantine or placebo once a day (q.d.) Week 1: 5 mg memantine or placebo twice a day (b.i.d.) Week 2-3: 5 mg memantine or placebo once in the morning (q.a.m.)/10 mg once in the evening (q.p.m.) Week 4-12: 10mg Memantine or placebo b.i.d.; Inactive comparator. Placebo-matching memantine tablet.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar disorder; Cognitive dysfunction; Memantine; NMDA antagonist

Summary:

      The purpose of this study is to see whether memantine improves memory function in
      participants with bipolar disorder who have minimal symptoms. Secondary analyses will test
      the role of memantine in improving residual mood symptoms (depression and mania) in
      participants with bipolar disorder.

      We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine
      will be effective in improving cognitive functions, as measured by the difference in
      neuropsychological test scores at the beginning and at the end of the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for any bipolar
             disorder [type I, type II, and not otherwise specified (NOS)] (diagnosed with the use
             of the Structured Clinical Interview for DSM-IV-TR Mood Module (SCID Mood Module)

          -  Written informed consent

          -  Men or women aged 18-65

          -  A baseline Hamilton-D 17 score of < 10 at screen and baseline visits.

          -  A baseline Young Mania Rating Scale score of < 10 at screen and baseline visits.

          -  No acute episodes of depression or mania for the previous 12 weeks.

          -  Massachusetts General Hospital Cognitive and Physical Functioning Scale: Cut-off: >15
             or Everyday Cognition Self-Report Form: Average of all items >1.5 or Repeatable
             Battery for the Assessment of Neuropsychological Status (RBANS): <12 years education,
             RBANS total scale score of <85 =12 years education, RBANS total scale score of <93 >12
             years education, RBANS total scale score of <100

          -  Able to read and understand English.

        Exclusion Criteria:

        Patients meeting any of the following criteria will be excluded from the study:

          -  Participants with suicidal ideation where outpatient treatment is determined unsafe by
             the study clinician. These patients will be immediately referred to appropriate
             clinical treatment.

          -  Pregnant women, nursing mothers, or women of childbearing potential who are not using
             a medically accepted means of contraception (defined as oral contraceptive pill or
             implant, condom, diaphragm, spermicide, intrauterine device (IUD), s/p tubal ligation,
             partner with vasectomy).

          -  Serious or unstable medical illness, including liver impairment, kidney impairment,
             cardiovascular, hepatic, respiratory, endocrine, neurologic or hematologic disease.

          -  History of seizure disorder, brain injury, any history of known neurological disease
             [multiple sclerosis, degenerative disease such as amyotrophic lateral sclerosis (ALS),
             Parkinson disease and any movement disorders, etc].

          -  History or current diagnosis of the following DSM-IV psychiatric illness: organic
             mental disorder, schizophrenia, schizoaffective disorder, delusional disorder,
             psychotic disorders not otherwise specified, major depressive disorder, patients with
             substance dependence disorders, including alcohol, active within the last 12 months.

          -  History of multiple adverse drug reactions.

          -  Patients with mood congruent or mood incongruent psychotic features within the last 12
             months.

          -  Clinical or laboratory evidence of hypothyroidism.

          -  Patients who have had an episode of acute depression or mania during the 12 weeks
             prior to enrollment.

          -  Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding
             enrollment.

          -  Patients taking drugs which alkalinize the urine.