Trial Outcomes & Findings for Lamotrigine Monotherapy in Pediatric Bipolar Disorder (NCT NCT00176228)

In the University of Illinois. The duration of the trial is 14 weeks, with initial 8 weeks of dose titration, followed by 6 weeks of administering the full dose.

To participate, subjects were required to consent to being washed out of their current medications at study entry. The washout period consisted of tapering their previous medications over one week prior to study entry except for those who received aripiprazole or fluoxetine who required a 4-week washout period.

Lamotrigine Monotherapy in Pediatric Bipolar Disorder

This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.

Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children's Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.