NCT00661869

Brief Summary

Obesity is increasing at an alarming rate in patients with schizophrenia, possibly in association with the increased use of atypical antipsychotics. In order to address the weight and metabolic syndrome issues, Manhattan Psychiatric Center (MPC) has implemented the Solutions for Wellness and Team Solutions Program. This program is designed to create a supportive, educational and monitoring environment to stabilize both the psychiatric and medical conditions and to prepare patients for independent management of their psychiatric and physical health condition in the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable 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

September 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

1 year

First QC Date

April 16, 2008

Last Update Submit

August 6, 2010

Conditions

SchizophreniaSchizoaffective DisorderBipolar Disorder

Outcome Measures

Primary Outcomes (2)

  • Pre and post-test knowledge assessments attained from each module

    36 weeks

  • Change in weight, abdominal girth, blood pressure, metabolic markers (Glucose , Insulin, C-peptide, Glycohemoglobin, total cholesterol, total triglycerides, HDL and LDL, leptin, and free fatty acid (FFA))

    36 weeks

Secondary Outcomes (1)

  • Systolic and diastolic blood pressure

    36 weeks

Study Arms (1)

Wellness Group

ACTIVE COMPARATOR
Other: Wellness Program

Interventions

Wellness ProgramOTHER

36 weeks of educational and supportive interventions

Wellness Group

Eligibility Criteria

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

You may qualify if:

  • Are at lease 18 years of age; ≤ 65 years.
  • Are male or female
  • Are currently hospitalized at Manhattan Psychiatric Center and attend daily treatment mall programs.
  • Are fluent in the language of the investigator, and study staff (including testing administrators, group leaders and supervisors)
  • Have a documented current psychiatric diagnosis as obtained from patient's medical charts and recorded by a qualified psychiatrist.
  • Recently admitted patients will be included if their clinical state permits it.

You may not qualify if:

  • Are \> 65 years of age;
  • Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Psychiatric Center

New York, New York, 10035, United States

Location

Related Publications (2)

  • Menza M, Vreeland B, Minsky S, Gara M, Radler DR, Sakowitz M. Managing atypical antipsychotic-associated weight gain: 12-month data on a multimodal weight control program. J Clin Psychiatry. 2004 Apr;65(4):471-7.

    PMID: 15119908BACKGROUND

  • Lindenmayer JP, Czobor P, Volavka J, Citrome L, Sheitman B, McEvoy JP, Cooper TB, Chakos M, Lieberman JA. Changes in glucose and cholesterol levels in patients with schizophrenia treated with typical or atypical antipsychotics. Am J Psychiatry. 2003 Feb;160(2):290-6. doi: 10.1176/appi.ajp.160.2.290.

    PMID: 12562575BACKGROUND

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar Disorder

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jean-Pierre Lindenmayer, M.D.

    New York University School of Medicine & Manhattan Psychaitric Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

January 1, 2008

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

US(1)