Medication, Weight Gain and GI Hormones

NCT00384332 | Completed Phase 4 Results DMC

• 1 other identifier: 051235
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.

Conditions

Bipolar Depression

Keywords

Bipolar Depression; Weight gain bipolar medicine; side effects olanzapine; gastrointestinal hormones bipolar medicine

Outcome Measures

Primary Outcomes (1)

• Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8

  Change in weight from baseline to endpoint in kilograms. Reported as weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8

  10 weeks

Secondary Outcomes (1)

• Change From Baseline Montgomery Asberg Depression Rating Scale

  10 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Orally disintegrating olanzapine

Drug: orally-disintegrating olanzapine

Arm 2

EXPERIMENTAL

regular olanzapine

Drug: regular olanzapine

Interventions

orally-disintegrating olanzapine DRUG

5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.

Also known as: Zydis

Arm 1

regular olanzapine DRUG

5-20 mg. olanzapine daily for approximately 8 weeks.

Also known as: Zyprexa

Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A principal diagnosis of bipolar 1 or II disorder
• Ages 18-60
• Physically healthy
• Outpatient status
• Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15
• BMI 23-30
• Able and willing to give written informed consent

You may not qualify if:

• Prior history of diabetes (types I or II)
• BMI\>30
• Non-fasting blood glucose \>124
• Fasting blood glucose \>125 or random blood glucose \>200
• Presence of dyslipidemia (baseline total cholesterol \>240, HDL\<50, LDL\>160, triglycerides \>199)
• Current or past history of a non-affective psychotic disorder
• Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine)
• Current use of any nicotine products
• Schizoid, schizotypal, or borderline personality disorder
• Treatment with olanzapine in the prior 3 months or any history of non- response to or intolerance of olanzapine or the olanzapine-fluoxetine combination (SymbiaxTM)
• Suicide potential that, in the opinion of the investigator, precludes outpatient treatment or participation in a trial
• Participation of subjects in another drug trial within 30 days of evaluation
• The presence of any current medical condition judged by the investigator to potentially interfere with the study procedures or measures
• The likelihood of requiring hospitalization over the period of the study
• The presence of any clinically-significant laboratory abnormality as judged by the investigator

Sponsors & Collaborators

• Vanderbilt University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (11)

• Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, Mitchell PB, Centorrino F, Risser R, Baker RW, Evans AR, Beymer K, Dube S, Tollefson GD, Breier A. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry. 2003 Nov;60(11):1079-88. doi: 10.1001/archpsyc.60.11.1079.

  PMID: 14609883 BACKGROUND

• Shelton RC. Treating bipolar depression. J Fam Pract. 2003 Mar;Suppl:S14-7. No abstract available.

  PMID: 12676079 BACKGROUND

• Farwell WR, Stump TE, Wang J, Tafesse E, L'Italien G, Tierney WM. Weight gain and new onset diabetes associated with olanzapine and risperidone. J Gen Intern Med. 2004 Dec;19(12):1200-5. doi: 10.1111/j.1525-1497.2004.40126.x.

  PMID: 15610330 BACKGROUND

• eder-Ischia U, Ebenbichler C, Fleischhacker WW. Olanzapine-induced weight gain and disturbances of lipid and glucose metabolism. Essent Psychopharmacol. 2005;6(2):112-7.

  PMID: 15765795 BACKGROUND

• Smith RC, Lindenmayer JP, Bark N, Warner-Cohen J, Vaidhyanathaswamy S, Khandat A. Clozapine, risperidone, olanzapine, and conventional antipsychotic drug effects on glucose, lipids, and leptin in schizophrenic patients. Int J Neuropsychopharmacol. 2005 Jun;8(2):183-94. doi: 10.1017/S1461145705005110.

  PMID: 15737248 BACKGROUND

• Cohen D. Diabetes mellitus during olanzapine and quetiapine treatment in Japan. J Clin Psychiatry. 2005 Feb;66(2):265-6; author reply 266-7. doi: 10.4088/jcp.v66n0217b. No abstract available.

  PMID: 15705015 BACKGROUND

• Gill SS. Stable monotherapy with clozapine or olanzapine increases the incidence of diabetes mellitus in people with schizophrenia. Evid Based Ment Health. 2005 Feb;8(1):24. doi: 10.1136/ebmh.8.1.24. No abstract available.

  PMID: 15671515 BACKGROUND

• Zimmermann U, Kraus T, Himmerich H, Schuld A, Pollmacher T. Epidemiology, implications and mechanisms underlying drug-induced weight gain in psychiatric patients. J Psychiatr Res. 2003 May-Jun;37(3):193-220. doi: 10.1016/s0022-3956(03)00018-9.

  PMID: 12650740 BACKGROUND

• Tecott LH, Sun LM, Akana SF, Strack AM, Lowenstein DH, Dallman MF, Julius D. Eating disorder and epilepsy in mice lacking 5-HT2c serotonin receptors. Nature. 1995 Apr 6;374(6522):542-6. doi: 10.1038/374542a0.

  PMID: 7700379 BACKGROUND

• Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, Steinberg S, Ernsberger P, Jayathilake K, Meltzer HY, Roth BL. H1-histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacology. 2003 Mar;28(3):519-26. doi: 10.1038/sj.npp.1300027.

  PMID: 12629531 BACKGROUND

• Bobo WV, Epstein RA Jr, Shelton RC. Effects of orally disintegrating vs regular olanzapine tablets on body weight, eating behavior, glycemic and lipid indices, and gastrointestinal hormones: a randomized, open comparison in outpatients with bipolar depression. Ann Clin Psychiatry. 2011 Aug;23(3):193-201.

  PMID: 21808751 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Treatment was not blinded to participants or treating physicians.

Results Point of Contact

• Title: Candace Cromer
• Organization: University of Alabama at Birmingham

clreed@uab.edu

2059753442

Study Officials

• Richard C. Shelton, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-06

Locations

US (1)