Melatonin for Reducing Weight Gain Following Administration of Atypical Antipsychotic Olanzapine for Adolescents with Bipolar Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.
OBJECTIVE
We aimed to evaluate melatonin effectiveness in weight gain reduction following olanzapine use for 11-17-year-old bipolar disorder patients.


METHODS
Seventy-seven adolescent outpatients, subsequent to their initial diagnosis of bipolar I disorder by a psychiatrist, entered this study. After assessing inclusion and exclusion criteria, 48 patients consented to participate. Twenty-four patients were allocated to receive olanzapine, lithium carbonate, and melatonin, and 24 patients were allocated to receive olanzapine, lithium carbonate, and placebo by simple randomization. The Young Mania Rating Scale (YMRS) was performed at baseline. Before treatment and after 6 and 12 weeks of treatment, weight, height, and body mass index (BMI) were measured. Analysis of variance (ANOVA) with repeated measure and t-test were used to analyze data.


RESULTS
Nineteen patients in each group finished the study and their data were entered for analysis. Mean rise in BMI in the melatonin group compared with placebo (2.45 vs. 3.25 respectively) was marginally significant (t = 1.936; df = 36; p = 0.061). ANOVA with repeated measure also showed a marginally significant difference (F = 3.74; df = 1; p = 0.061) between groups and across time in regard to BMI. Mean body weight rise in the melatonin group compared with the placebo group (5.8 kg vs. 8.2 kg respectively) was marginally significant (t = 1.923; df = 28; p = 0.065). ANOVA with repeated measure also showed a marginally significant difference (F = 3.73; df = 1.1; p = 0.056) between groups and across time for body weight.


CONCLUSIONS
Coadministration of melatonin with olanzapine and lithium carbonate in adolescents with bipolar disorder could reduce the sharp weight gain side effect of these drugs to near significance.
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
Seyed-Ali
SA
Mostafavi
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
Mahmoud
M
Solhi
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
Mohammad-Reza
MR
Mohammadi
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
Shahin
S
Akhondzadeh
D000293:Adolescent; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001569:Benzodiazepines / Q000009:adverse effects* / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000188:drug therapy; D001835:Body Weight / Q000187:drug effects; D002648:Child; D004311:Double-Blind Method; D006801:Humans; D016651:Lithium Carbonate / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D000077152:Olanzapine; D011569:Psychiatric Status Rating Scales; D013997:Time Factors; D015430:Weight Gain / Q000187:drug effects*
D018692:Antimanic Agents; D014150:Antipsychotic Agents; D001569:Benzodiazepines; D016651:Lithium Carbonate; D008550:Melatonin; D000077152:Olanzapine
antipsychotic agents; body weight; melatonin; olanzapine; weight gain