NCT00351936

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

January 28, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1.6 years

First QC Date

July 12, 2006

Results QC Date

December 20, 2012

Last Update Submit

January 30, 2013

Conditions

Schizophrenia

Keywords

SchizophreniaDiabetesObesityOlanzapineInsulin Resistance

Outcome Measures

Primary Outcomes (7)

  • Change From Baseline in Weight (Lbs)

    Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

  • Change From Baseline in Body Mass Index (BMI)

    Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

  • Change From Baseline in Waist-hip Ratio (WHR)

    Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

  • Change From Baseline in Fasting Total Cholesterol

    Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

  • Change From Baseline in Low-density Lipoprotein (LDL)

    Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

  • Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

    Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

  • Change From Baseline in Triglycerides

    Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.

    baseline, week 4

Study Arms (2)

Aripiprazole

ACTIVE COMPARATOR

aripiprazole 15mg/day

Drug: Aripiprazole

placebo

PLACEBO COMPARATOR

matched placebo for aripiprazole 15mg/day

Drug: placebo

Interventions

AripiprazoleDRUG
Aripiprazole
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age 18-65
  • Diagnosis of schizophrenia, any subtype, or schizoaffective disorder, any sub-type
  • Body mass index \> 30 Kg/m2 or \>27 Kg/m2 with other risk factors (HTN, Lipid abnormalities)
  • Well established compliance with outpatient medications.
  • Maintained on a stable dose of olanzapine for at least one month.

You may not qualify if:

  • Serious medical or neurological illness (unstable cardiac disease, malignancy, liver or renal impairment, etc.)
  • Current substance abuse
  • Psychiatrically unstable, which is defined as a score on the CGI's severity of illness question of 5 or greater or a baseline Total PANSS score \> 75
  • Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
  • Serious suicidal or homicidal risk within the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Related Publications (13)

  • 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.

    PMID: 10553730BACKGROUND

  • 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.

    PMID: 11775052BACKGROUND

  • 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.

    PMID: 9169300BACKGROUND

  • Beasley CM Jr, Tollefson GD, Tran PV. Safety of olanzapine. J Clin Psychiatry. 1997;58 Suppl 10:13-7.

    PMID: 9265911BACKGROUND

  • 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.

    PMID: 12796218BACKGROUND

  • 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.

    PMID: 10350036BACKGROUND

  • 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.

    PMID: 16423166BACKGROUND

  • 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.

    PMID: 3363019BACKGROUND

  • 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.

    PMID: 3774930BACKGROUND

  • 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.

    PMID: 10584766BACKGROUND

  • 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.

    PMID: 8363192BACKGROUND

  • Pi-Sunyer FX. The medical risks of obesity. Obes Surg. 2002 Apr;12 Suppl 1:6S-11S. doi: 10.1007/BF03342140.

    PMID: 11969107BACKGROUND

  • 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.

    PMID: 10401912BACKGROUND

MeSH Terms

Conditions

SchizophreniaDiabetes MellitusObesityInsulin Resistance

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The small sample size and the short duration of active treatment and washout period may have prevented detection of other metabolic benefits, including possible reductions in fasting insulin and insulin resistance (measured by HOMA-IR).

Results Point of Contact

Title
Dr. David Henderson
Organization
Massachusetts General Hospital Schizophrenia Research Program
dchenderson@partners.org
(617) 912-7800

Study Officials

  • David C Henderson, MD

    North Suffolk Mental Health Association

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 13, 2006

Study Start

December 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 4, 2013

Results First Posted

January 28, 2013

Record last verified: 2013-01

Locations

US(1)