deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT00176436

Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine

Sponsor: Eli Lilly and Company

Conditions Schizophrenia
Updated 12 times since 2017 Last updated: Mar 1, 2022 Started: Feb 29, 2004 Primary completion: Mar 31, 2008 Completion: Mar 31, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Schizophrenia and is currently completed. Eli Lilly and Company leads this study, which shows 12 recorded versions since 2004 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Study Description(click to expand)

The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.

The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Sep 2019 · 15 months · monthly snapshotCompleted~Sep 2019 – ~Dec 2019 · 3 months · monthly snapshotCompleted~Dec 2019 – ~Jan 2021 · 13 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotCompleted~Apr 2022 – ~Dec 2022 · 8 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE4

Show 7 earlier versions
  1. Apr 2022 — Dec 2022 [monthly]

    Completed PHASE4

  2. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE4

  3. Dec 2019 — Jan 2021 [monthly]

    Completed PHASE4

  4. Sep 2019 — Dec 2019 [monthly]

    Completed PHASE4

  5. Jun 2018 — Sep 2019 [monthly]

    Completed PHASE4

  6. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  7. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Feb 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eli Lilly and Company
  • University of Maryland, Baltimore
Data source: University of Maryland, Baltimore

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations