An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder
Condition: Mood Disorders
MeSH terms: Mood Disorders
Intervention: Lamotrigine
Intervention description: Experimental formulation
Intervention MeSH terms: Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mood disorder

Summary:

      To determine the convenience and satisfaction of new orally disintegrating tablet formulation
      (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study
      in participants with a mood disorder, who reported difficulty or discomfort in swallowing the
      currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such
      as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a
      Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine
      IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3
      weeks to determine convenience and satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have a documented diagnosis of a mood disorder as defined by Diagnostic
             and Statistical Manual of Mental Disorders (DSM)-IV (296.00-296.90).

          -  Subject must have a person (such as a spouse, partner, companion, aid, nurse,
             caregiver, etc) willing to complete a Companion/Caregiver Preference Question either
             in person or via the telephone. This individual must read, write, and comprehend
             English at a level sufficient to complete study-related assessments.

          -  Subject must have been taking a stable dose of currently marketed compressed tablet
             formulation of lamotrigine IR for at least 4 weeks prior to Baseline (Day 1) of the
             study and must be adherent to the prescribed dosing regimen. The current dose must not
             exceed 600 mg/day.

          -  Subject's current lamotrigine IR dose, frequency and number of tablets per
             administration must remain consistent between the IR and ODT regimens. However, the
             subject's current lamotrigine IR dose may be such that the subject would receive no
             more than one additional ODT per administration in order to equal their IR dose.

          -  Subject must currently report a difficulty or discomfort swallowing lamotrigine IR
             compressed tablets, the nature of which is or will be documented. NOTE: A diagnosis of
             dysphagia is not required.

          -  Subject must have the ability to comprehend the consent form and provide informed
             consent.

          -  Subject must read, write, and comprehend English at a level sufficient to complete
             study-related assessments.

          -  Subject is a male or female at least 18 years of age.

          -  If female, the subject is eligible to enter and participate in this study if she is
             not lactating and is of:

               1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
                  including any female who is pre-menarchal or post-menopausal [defined as one year
                  without menses]); is surgically sterile [via hysterectomy and/or removal of the
                  ovaries] or,

               2. child-bearing potential, has a negative pregnancy test at both Screening and/or
                  Baseline (prior to Investigational Product administration), and agrees to one of
                  the following requirements:

          -  has a male sexual partner who is surgically sterilized (vasectomy with documentation
             of azoospermia) prior to Screening or,

          -  sexual partner(s) is/are exclusively female or,

          -  double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus
             spermicidal agent (foam/gel/film/cream/suppository). The subject must be using this
             method for at least 1 week following the discontinuation of Investigational Product
             or,

          -  any intrauterine device (IUD) with published data showing that the highest expected
             failure rate is less than 1% per year. Acceptable IUDs, for the purposes of this
             study, include TCu-380A (Paragard), TCU-380 Slimline (Gyne T Slimline), MULTILOAD-250
             (MLCu-250) and 375, Levonorgesterol LNG-20 Intrauterine System (Mirena/Levonova), and
             Flexigard 330/CuFix PP330 (Gynefix).The subject must have had the device inserted at
             least 2 weeks prior to Screening, throughout the study, and 2 weeks following the
             discontinuation of Investigational Product.

        Exclusion Criteria:

          -  Subject has:

          -  a current (or within six months prior to Screening) diagnosis of anorexia nervosa or
             bulimia.

          -  a diagnosis of a mood disorder due to a general medical condition, or substance abuse
             per DSM-IV (293.83).

          -  a diagnosis of schizophrenia or other psychotic disorders.

          -  Subject who meets current criteria of an acute mood disorder and has a CGI-S of ≥4 at
             Screening.

          -  Subject who crushes lamotrigine IR compressed tablet prior to taking or receiving
             medication orally.

          -  Subject who, in the investigator's judgment, poses a homicidal or serious suicidal
             risk; has made a suicide attempt within the six months preceding Screening; or has
             ever been homicidal.

          -  Subject who has a score of 1 or greater on Suicidality item (Item 9) of the BDI-II at
             Screening and/or Baseline.

          -  Subject has ever experienced a rash related to prior lamotrigine treatment, or for
             whom treatment was discontinued for clinically significant safety reasons.

          -  Subject has a history of severe hepato-biliary disease within the past 3 years.

          -  Subject has any medical condition that, in the investigator's judgment, is considered
             to be clinically significant and could potentially affect subject safety or study
             outcome.

          -  Subject has a positive urine test at Screening for illicit drug use and/or a history
             of alcohol or substance abuse or dependence within the past 12 months.

          -  Subject is currently participating in another clinical study in which the subject is
             or will be exposed to an investigational or non-investigational drug or device, or has
             done so within the preceding month for studies unrelated to the current illness, or
             six months for studies related to the current illness.

          -  Female subject is pregnant, lactating, or does not agree to use contraceptive
             method(s) specified in the protocol to avoid pregnancy during the study.