An exploratory open-label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia.
OBJECTIVE
We conducted this 6-week open-label trial to examine the effects of adjunctive aripiprazole in clozapine-treated subjects on weight, lipid and glucose metabolism, as well as positive and negative symptoms of schizophrenia.


METHODS
Ten clozapine-treated subjects received aripiprazole augmentation; eight completed the 6-week trial and two ended at week 4. Eighty percent were male, the mean age was 38.7 +/- 8.9 years and the mean clozapine dose was 455 +/- 83 mg daily.


RESULTS
There was a significant decrease in weight (P = 0.003), body mass index (P = 0.004), fasting total serum cholesterol (P = 0.002) and total triglycerides (P = 0.04) comparing baseline to study endpoint. There was no significant change in total Positive and Negative Syndrome Scale scores.


CONCLUSIONS
This combination may be useful for clozapine-associated medical morbidity and must be studied in placebo-controlled double-blind randomized trials to determine efficacy and safety.
Henderson
D C
DC
Schizophrenia Program, Massachusetts General Hospital, Boston, MA, USA. dchenderson@partners.org.
Kunkel
L
L
Nguyen
D D
DD
Borba
C P
CP
Daley
T B
TB
Louie
P M
PM
Freudenreich
O
O
Cather
C
C
Evins
A E
AE
Goff
D C
DC
D000328:Adult; D000553:Ambulatory Care; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068180:Aripiprazole; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D003024:Clozapine / Q000008:administration & dosage* / Q000009:adverse effects; D003155:Community Mental Health Centers; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy*; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D014280:Triglycerides / Q000097:blood
D014150:Antipsychotic Agents; D001786:Blood Glucose; D010879:Piperazines; D015363:Quinolones; D014280:Triglycerides; D000068180:Aripiprazole; D002784:Cholesterol; D003024:Clozapine