Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State

NCT00490542 | Completed Phase 2 Results

• 1 other identifier: GA128000
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 4

Brief Summary

Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued that mixed states were the most common episodes in manic-depressive illness. A mixed state is defined as a person who is experiencing symptoms of both depression and mania. Currently, a person must have depression plus 3 or more manic symptoms for the episode to be diagnosed mixed. Using this narrow view, less than 10% of episodes in patients with bipolar disorder would meet criteria for a mixed episode. A broader view requires that the person have at least 2 manic symptoms. Using this broader view, data suggest that about 50% of episodes in bipolar disorder would be diagnosable as mixed states. Studies suggest that the majority of persons with a depressive mixed state have bipolar disorder type II. Many people who have a mixed state will also have major depression. Even with such high potential rates of mixed episodes in both bipolar disorder and major depression, there have been few studies addressing the issue. The purpose of this study is to look at how effective Geodon is in treating the depressive mixed state in people with bipolar or major depression. This will be the first clinical trial that is both double-blind and randomized.

Conditions

Bipolar Disorder; Bipolar Depression; Depression

Keywords

Bipolar Disorder; Major Depression; Clinical pharmacology; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.

  Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.

  Baseline to 6 weeks

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

Participants were instructed by a physician to take a study drug daily. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone. Participants were not informed whether they were receiving sugar pills or Geodon. Participants in this study arm received sugar pills.

Drug: placebo

Geodon arm

ACTIVE COMPARATOR

Participants were instructed by a physician to take a study drug daily. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone. Participants were not informed whether they were receiving sugar pills or Geodon. Participants in this study arm received Geodon.

Drug: ziprasidone (Geodon)

Interventions

ziprasidone (Geodon) DRUG

ziprasidone, geodon. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.

Geodon arm

placebo DRUG

Placebo, sugar pill arm. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of bipolar disorder type II, or unipolar major depressive disorder
• If female, non-pregnant/non-lactating
• If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)
• Currently meets Diagnostic and Statistical Manual, 4th edition (DSM-IV) criteria for a major depressive episode, and presence of 2 or 3 DSM-IV manic criteria, present for the majority of the time during the past week.
• All other baseline psychotropic drugs will be allowed to be continued unchanged. However, if antidepressant use has been initiated in the previous 2 months, or was thought to be contributing to the depressive mixed state, then antidepressant medications would be discontinued 4 weeks before starting the study.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Pfizer: collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60201, United States

Location

Tufts University

Boston, Massachusetts, 02111, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Duke University

Durham, North Carolina, 27704, United States

Location

Related Publications (1)

• Patkar A, Gilmer W, Pae CU, Vohringer PA, Ziffra M, Pirok E, Mulligan M, Filkowski MM, Whitham EA, Holtzman NS, Thommi SB, Logvinenko T, Loebel A, Masand P, Ghaemi SN. A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state. PLoS One. 2012;7(4):e34757. doi: 10.1371/journal.pone.0034757. Epub 2012 Apr 24.

  PMID: 22545088 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depression; Depressive Disorder, Major

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder

Limitations and Caveats

One potential limitation in relation to secondary analyses would be sample size. The randomized study design should account for most potential confounding effects, but residual confounding cannot be completely eliminated without larger studies.

Results Point of Contact

• Title: S. Nassir Ghaemi, MD, MPH
• Organization: Tufts Medical Center

nghaemi@tuftsmedicalcenter.org

617-636-5735

Study Officials

• Nassir Ghaemi, MD, MPH

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: December 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 29, 2016
• Results First Posted: January 8, 2014

Record last verified: 2016-07

Locations

US (4)