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NCT01293825 · ClinicalTrials.gov registry record · Phase 4

Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

A Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target

NCT01293825: Completed Phase 4 study, sponsored by University Hospitals Cleveland Medical Center.

NCT01293825 is a Phase 4 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01293825, a Phase 4 study, has completed, sponsored by University Hospitals Cleveland Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study Summary

Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.

Primary Outcome

Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.

Interventions

  • DRUG ziprasidone

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-01
Est. Completion 2012-08
Phase Phase 4

What the finished NCT01293825 record still lists

NCT01293825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which ziprasidone is the first listed.

NCT01293825 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01293825 about?

NCT01293825 is a clinical study titled "Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)". Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizi...

What is the current status of trial NCT01293825?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2011-01. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01293825?

The interventions under investigation include: ziprasidone (DRUG).

Who is sponsoring clinical trial NCT01293825?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01293825's enrollment target sits among peer trials

30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01293825, the US trial registry maintained by the National Library of Medicine. NCT01293825 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.