A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder

NCT00555997 | Completed Phase 2 Results

• 1 other identifier: 2007-P-000623
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

This is a study on the effectiveness, tolerability and safety of oral ziprasidone as monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD will be treated with either ziprasidone or placebo for 12 weeks. Hypothesis: There will be a statistically significant difference in the magnitude of response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be greater in the ziprasidone monotherapy group than in the placebo group.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Major Depression; Depression; Geodon; Ziprasidone

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D-17) Scores

  Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.

  6 weeks

Secondary Outcomes (2)

• Responder/Non-responder

  6 weeks

• Change in 6-VAS-D Scores During Each Phase.

  6 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Patients in group 1 will receive Ziprasidone for the full 12 weeks of the study.

Drug: Ziprasidone

2

ACTIVE COMPARATOR

Patients in Group 2 will receive placebo for the first 6 weeks of the study, then will receive Ziprasidone for the last 6 weeks.

Drug: Ziprasidone

3

PLACEBO COMPARATOR

Patients in Group 3 will receive placebo for the full 12 weeks of the study.

Drug: Placebo

Interventions

Ziprasidone DRUG

20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.

Also known as: Geodon

1

Placebo DRUG

0mg Placebo per day. "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo

3

Eligibility Criteria

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

You may qualify if:

• Age 18-65.
• Written informed consent.
• MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
• Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.

You may not qualify if:

• Pregnant women.
• Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
• Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
• Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
• Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
• Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
• Patients who meet criteria for alcohol or substance dependence, active within the last month.
• Any bipolar disorder (current or past).
• Any psychotic disorder (current or past).
• Psychotic features in the current episode or a history of psychotic features.
• History of a seizure disorder.
• Clinical or laboratory evidence of untreated hypothyroidism.
• Patients requiring excluded medications (see table 1 for details).
• Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
• Any investigational psychotropic drug within the last 3 months.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Cambridge Health Alliance: collaborator
• University of Connecticut: collaborator
• Vanderbilt University: collaborator
• Psychiatric Medicine Associates, L.L.C.: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (7)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030-6415, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Psychiatric Medicine Associates, L.L.C.

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

• Papakostas GI, Vitolo OV, Ishak WW, Rapaport MH, Zajecka JM, Kinrys G, Mischoulon D, Lipkin SH, Hails KA, Abrams J, Ward SG, Meisner A, Schoenfeld DA, Shelton RC, Winokur A, Okasha MS, Bari MA, Fava M. A 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. J Clin Psychiatry. 2012 Dec;73(12):1541-7. doi: 10.4088/JCP.12m07670.

  PMID: 23290327 RESULT

• Heo JY, Jeon HJ, Fava M, Mischoulon D, Baer L, Clain A, Doorley J, Pisoni A, Papakostas GI. Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial. J Psychiatr Res. 2015 Mar;62:56-61. doi: 10.1016/j.jpsychires.2015.01.007. Epub 2015 Jan 26.

  PMID: 25659187 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. George Papakostas
• Organization: Massachusetts General Hospital

gpapakostas@partners.org

617-726-6697

Study Officials

• George I Papakostas, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• John M Zajecka, M.D.

  Psychiatric Medicine Associates, L.L.C.

  PRINCIPAL INVESTIGATOR

• Richard C Shelton, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Andrew Winokur, M.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

• Gustavo Kinrys, M.D.

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

• Waguih IsHak, M.D.

  Cedar's Sinai

  PRINCIPAL INVESTIGATOR

• Mahmoud S Okasha, MD

  Comprehensive Psychiatric Care, Norwich CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Director of Treatment-Resistant Studies, Depression Clinical and Research Program

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-06

Locations

US (7)