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Lisinopril 5 mg online ) or aspirin (400 mg) with each meal. Patients were given a 5-day supply of tablets on the day randomization. first 1–2 pills of each 5-day supply were not allowed to be swallowed.
To evaluate safety, drug-related adverse events, vital signs, and the extent of drug absorption, study was designed as an active-controlled test in healthy volunteers.
Study Eligibility
Inclusion criteria were: 1) normal age or young adult; 2) a satisfactory clinical response to baseline treatment with lamotrigine or placebo; 3) no history of drug hypersensitivity (including eosinophilia); and 4) no contraindications for drug treatment including history of hypersensitivity, use concomitant medications, medication, coagulation abnormalities, diabetes mellitus, or thyroid disease.
Exclusion criteria were: 1) history of liver or kidney cirrhosis; 2) prior therapy with valproic acid, carbamazepine, phenytoin, rifampin, or sulfonamides; 3) a history of hypersensitivity to any monosodium molar, other than the drug or placebo; 4) recent chronic renal disorder; 5) concurrent use of immunosuppressants; 6) treatment with drugs activity against CYP1A2, CYP2C19, or CYP3A4 that could affect the kinetics of lamotrigine; 7) active thyroid dysfunction as demonstrated by a urinary 4-hydroxynonenal concentration >4 μmol/L or an increase in serum thyrotropin concentration >2.5 μg/L, or both; 8) use of concomitant immunosuppressants; 9) recent or chronic hepatitis B C infection; or 10) use of other medications that might reduce the clearance of lamotrigine.
Study Design and Participants
Forty patients with bipolar disorder (n = 16 in the Lamictal group, n = 16 in the Placebo group) and a minimum of 6 years illness were randomly assigned (1:1) to receive:
Lamictal 10 mg and 25 (n = 15 each group); or
Placebo (n = 15 each group).
Study visits were conducted by a psychiatrist at the clinic of Dr. John A. Gershenfeld, MD, in San Diego, with a follow-up phone call conducted 2 weeks and 6 months after randomization. The protocol required that patients be informed of the study drug during previous visit, followed by a detailed description of the study and its procedures at the clinic visit. Patients underwent blood sampling for determination of lamotrigine plasma concentrations, chemistry, organ function test results, and quality-of-life assessments at all study visits.
Lamictal and Placebo Side-Effects
The usual doses and durations of lamotrigine treatment in the trial have been reported in detail previously.20,21 At study entry, all patients were screened for drug allergies and intolerances, including thyroid, hepatic, kidney disease. The drug-induced adverse events were monitored during the study.20,21
Patients were assessed in two ways during each study visit.
Lisinopril is used for treating high blood pressure alone or with other medicines.
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