Table 8 shows the percentage of adult patients with weight gain of ≥7% of body weight for MDD by dose.

 Table 8: Percentage of Patients with Weight Gain ≥7% of Body Weight in MDD Adjunctive Therapy Trials by Dose (Adults)

Table 8  Vital sign Treatment Arm N Patients
n (%)
Weight Gain ≥7% of Body in MDD Adjunctive Therapy
 Placebo
 302
 5 (2%)
 
SEROQUEL XR 150 mg
 309
 10 (3%)
 
SEROQUEL XR 300 mg
 307
 22 (7%)
 

Children and Adolescents: Safety and effectiveness of SEROQUEL XR have not been established in pediatric patients and SEROQUEL XR is not approved for patients under the age of 18 years. In two clinical trials with SEROQUEL, one in bipolar mania and one in schizophrenia, reported increases in weight are included in table 9 below.

 Table 9 shows the percentage of patients with weight gain ≥7% of body weight in clinical trials with SEROQUEL.

 Table 9: Percentage of Patients with Weight Gain ≥7% of Body Weight (Children and Adolescents)

Table 9  Vital Sign Indication Treatment Arm N Patients
n (%)
*
: 6 weeks duration
†
: 3 weeks duration 
Weight gain
 Schizophrenia*
 SEROQUEL
 111
 23 (21%)
 
Placebo
 44
 3 (7%)
 
Bipolar Mania†
 SEROQUEL
 157
 18 (12%)
 
Placebo
 68
 0 (0%)
The mean change in body weight in the schizophrenia trial was 2.0 kg in the SEROQUEL group and -0.4 kg in the placebo group and in the bipolar mania trial it was 1.7 kg in the SEROQUEL group and 0.4 kg in the placebo group.

In an open-label study that enrolled patients from the above two pediatric trials, 63% of patients (241/380) completed 26 weeks of therapy with SEROQUEL. After 26 weeks of treatment, the mean increase in body weight was 4.4 kg. Forty-five percent of the patients gained ≥ 7% of their body weight, not adjusted for normal growth. In order to adjust for normal growth over 26 weeks, an increase of at least 0.5 standard deviation from baseline in BMI was used as a measure of a clinically significant change; 18.3% of patients on SEROQUEL met this criterion after 26 weeks of treatment.

When treating p