Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo

NCT01920802 | Completed Phase 4 Results

• 1 other identifier: 6525
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot randomized clinical trial is to begin to delineate the pathophysiological changes associated with antipsychotic associated metabolic side effects. The study will be performed in 36 healthy people between the ages of 18 and 30, who have never taken an antipsychotic, will undergo baseline laboratory tests before being randomized to 5mg BID of olanzapine or 6mg BID of iloperidone or placebo to take for up to 4 weeks. The primary outcome measure will be a correlation of early changes in leptin with weight gain. We will also record changes in food intake, resting metabolic rate, oral glucose tolerance and fasting insulin and glucose levels, lipids and inflammation markers. Subjects will be followed closely to monitor for safety throughout the 4-week study and will be discontinued if there is a medically significant change in metabolic status or other antipsychotic side effects. Metabolic assessments will be performed again at the time of discontinuation or at the end of an 4-week period, and change from baseline in the two treatment groups will be compared.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight

  Delineate a pathophysiological mechanism of antipsychotic induced weight gain

  baseline and 6 week visit

• Change in Adiposity

  Total fat mass (excluding head) from baseline to Day 28

  Baseline to Day 28

Secondary Outcomes (1)

• Change in Leptin

  change in baseline to Day 3

Other Outcomes (5)

• Change Glucose in People Taking Olanzapine or Iloperidone

  Baseline to study termination (about 12 weeks)

• Change in Insulin

  Baseline to Day 28

• Insulin Resistance

  Baseline to Day 28

Study Arms (3)

olanzapine

EXPERIMENTAL

5mg BID olanzapine for up to 4 weeks

Drug: olanzapine

iloperidone

EXPERIMENTAL

6mg BID iloperidone up to 4 weeks

Drug: iloperidone

placebo

PLACEBO COMPARATOR

BID placebo up to 4 weeks

Drug: Placebo

Interventions

olanzapine DRUG

5mg BID up to 4 weeks

Also known as: Zyprexa

olanzapine

iloperidone DRUG

6 mg BID up to 4 weeks

Also known as: Fanapt

iloperidone

Placebo DRUG

BID up to 4 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between the ages of 18-35 with no history of any Axis-I diagnosis
• Does not meet criteria for substance abuse or dependence in the past six months
• Female subjects will use barrier-method, non-hormonal contraception
• Capacity to understand all the relevant risks and potential benefits of the study (informed consent)
• Must be able to speak and read English

You may not qualify if:

• Current or past Axis I psychiatric diagnosis, including alcohol or substance abuse or dependence (except nicotine or caffeine), but not including minor Axis I disorders (e.g. simple phobia)
• Lifetime use of psychotropic medications, including antipsychotics, antidepressants, mood stabilizers, and anxiolytics
• Presence or history of medical or neurological illness that, in the judgment of the investigator, could influence the results of the study
• Diagnosis of diabetes, hemoglobin A1C \> 6.5, hypertension, or dyslipidemias, or elevated random or fasting glucose, abnormal lipid levels, BP 130/85
• BMI 25 or \< 19, history of BMI \>35, and/or waist circumference \>35 inches for females, 40 inches for males
• Subjects who are pregnant or breast-feeding or planning to become pregnant during the study
• Acute suicidality
• Meets criteria for a Diagnostic and Statistical Manual, Version 4 (DSM-IV) defined eating disorder
• Use of, or clinical indication for, one or more of the following medications: lithium, anti-epileptic medication, steroids (oral or inhaled), stimulants, serotonin reuptake inhibitors, mirtazapine, tricyclic antidepressants, thyroid supplementation, sibutramine, metformin, thiazolidinediones, beta-blockers, clonidine, niacin
• Subjects who have had \>10% change in their body weight within the three months prior to enrollment
• HIV positive subjects
• Presence of mental retardation or pervasive developmental disorder
• History of recent (within 6 months) significant self-injurious behavior or violence
• Daily multivitamin or B-complex vitamin use
• A known history of dieting and difficulty with weight loss

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Ballon JS, Pajvani UB, Mayer LE, Freyberg Z, Freyberg R, Contreras I, Rosenbaum M, Leibel RL, Lieberman JA. Pathophysiology of drug induced weight and metabolic effects: findings from an RCT in healthy volunteers treated with olanzapine, iloperidone, or placebo. J Psychopharmacol. 2018 May;32(5):533-540. doi: 10.1177/0269881118754708. Epub 2018 Feb 15.

  PMID: 29444618 DERIVED

MeSH Terms

Interventions

Olanzapine; iloperidone

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jeffrey A. Lieberman, MD
• Organization: New York State Psychiatric Institute

jlieberman@columbia.edu

646-774-8436

Study Officials

• Jeffrey Lieberman, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 12, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Locations

US (1)