NCT00176436

Brief Summary

The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Feb 2004

Typical duration 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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

June 17, 2013

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

4.1 years

First QC Date

September 12, 2005

Results QC Date

January 18, 2013

Last Update Submit

March 1, 2022

Conditions

Schizophrenia

Keywords

Weight lossSupport groupExerciseAtomoxetine

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Weight

    Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.

    Weekly for 24 weeks

Secondary Outcomes (3)

  • Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.

    24 weeks

  • Vital Signs

    Weekly for 24 weeks

  • Chemistry Panel

    baseline, 10 weeks and 24 weeks

Study Arms (2)

active

ACTIVE COMPARATOR

Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. Diet support group, group counseling and exercise.

Behavioral: Group counseling and exercise

Placebo

PLACEBO COMPARATOR

Placebo medication, diet support group, group counseling and exercise

Behavioral: Diet support group

Interventions

Diet support groupBEHAVIORAL

Diet support group weekly and exercise sessions 3 times/week, placebo medication

Placebo
Group counseling and exerciseBEHAVIORAL

Support group weekly and exercise sessions 3 times/week for 24 weeks

active

Eligibility Criteria

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

You may qualify if:

  • Schizophrenia or schizoaffective Disorder
  • Taking olanzapine or clozapine for at least 6 months
  • Weight gain of 7% over baseline or BMI greater than or equal to 27

You may not qualify if:

  • Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
  • Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
  • Current treatment with other medications for weight loss unless weight stable for 6 months
  • Mental Retardation
  • Alcohol or Substance Dependence within the last 6 months
  • Pregnancy
  • Alcohol or Substance Abuse within the lat month
  • Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

Related Publications (1)

  • Ball MP, Warren KR, Feldman S, McMahon RP, Kelly DL, Buchanan RW. Placebo-controlled trial of atomoxetine for weight reduction in people with schizophrenia treated with clozapine or olanzapine. Clin Schizophr Relat Psychoses. 2011 Apr;5(1):17-25.

    PMID: 21459735RESULT

MeSH Terms

Conditions

SchizophreniaWeight LossMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
M. Patricia Ball, R.N., C.,M.S.
Organization
Maryland Psychiatric Research Center
pball@mprc.umaryland.edu
410-402-7663

Study Officials

  • M Patricia Ball, R.N.,C.,M.S.

    University of Maryland Baltimore Maryland Psychiatric Research Center

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Maryland Psychiatric Research Center, Outpatient Research Program

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

February 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 14, 2022

Results First Posted

June 17, 2013

Record last verified: 2022-03

Locations

US(1)