A Placebo-Controlled, Cross-Over Trial of Aripiprazole

Summary

This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own control and fewer subjects will be required than a between-group design.

Timeline

Start

2005-12

Primary completion

2007-07

Completion

2007-07

Publications

• Background Allison DB, Mentore JL, Heo M, Chandler LP, Cappelleri JC, Infante MC, Weiden PJ. Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999 Nov;156(11):1686-96. doi: 10.1176/ajp.156.11.1686.
• Background Baptista T, Beaulieu S. Body weight gain, insulin, and leptin in olanzapine-treated patients. J Clin Psychiatry. 2001 Nov;62(11):902-4. doi: 10.4088/jcp.v62n1111b. No abstract available.
• Background Beasley CM Jr, Hamilton SH, Crawford AM, Dellva MA, Tollefson GD, Tran PV, Blin O, Beuzen JN. Olanzapine versus haloperidol: acute phase results of the international double-blind olanzapine trial. Eur Neuropsychopharmacol. 1997 May;7(2):125-37. doi: 10.1016/s0924-977x(96)00392-6.
• Background Beasley CM Jr, Tollefson GD, Tran PV. Safety of olanzapine. J Clin Psychiatry. 1997;58 Suppl 10:13-7.
• Background Davis JM, Chen N, Glick ID. A meta-analysis of the efficacy of second-generation antipsychotics. Arch Gen Psychiatry. 2003 Jun;60(6):553-64. doi: 10.1001/archpsyc.60.6.553.
• Background Gupta S, Droney T, Al-Samarrai S, Keller P, Frank B. Olanzapine: weight gain and therapeutic efficacy. J Clin Psychopharmacol. 1999 Jun;19(3):273-5. doi: 10.1097/00004714-199906000-00014. No abstract available.
• Background Henderson DC, Kunkel L, Nguyen DD, Borba CP, Daley TB, Louie PM, Freudenreich O, Cather C, Evins AE, Goff DC. An exploratory open-label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia. Acta Psychiatr Scand. 2006 Feb;113(2):142-7. doi: 10.1111/j.1600-0447.2005.00612.x.
• Background Kay SR, Opler LA, Lindenmayer JP. Reliability and validity of the positive and negative syndrome scale for schizophrenics. Psychiatry Res. 1988 Jan;23(1):99-110. doi: 10.1016/0165-1781(88)90038-8.
• Background Levine J, Schooler NR. SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacol Bull. 1986;22(2):343-81. No abstract available.
• Background Osser DN, Najarian DM, Dufresne RL. Olanzapine increases weight and serum triglyceride levels. J Clin Psychiatry. 1999 Nov;60(11):767-70. doi: 10.4088/jcp.v60n1109.
• Background Pi-Sunyer FX. Medical hazards of obesity. Ann Intern Med. 1993 Oct 1;119(7 Pt 2):655-60. doi: 10.7326/0003-4819-119-7_part_2-199310011-00006.
• Background Pi-Sunyer FX. The medical risks of obesity. Obes Surg. 2002 Apr;12 Suppl 1:6S-11S. doi: 10.1007/BF03342140.
• Background Wirshing DA, Wirshing WC, Kysar L, Berisford MA, Goldstein D, Pashdag J, Mintz J, Marder SR. Novel antipsychotics: comparison of weight gain liabilities. J Clin Psychiatry. 1999 Jun;60(6):358-63.

Drugs

Indications