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

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

Interventions

DRUG

Ziprasidone

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.

DRUG

Ziprasidone

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.

DRUG

Placebo

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

Sponsors & Collaborators

• Cambridge Health Alliance

  collaborator OTHER

• University of Connecticut

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Psychiatric Medicine Associates, L.L.C.

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• George I Papakostas, M.D. · Massachusetts General Hospital

• John M Zajecka, M.D. · Psychiatric Medicine Associates, L.L.C.

• Richard C Shelton, M.D. · Vanderbilt University Medical Center

• Andrew Winokur, M.D. · UConn Health

• Gustavo Kinrys, M.D. · Cambridge Health Alliance

• Waguih IsHak, M.D. · Cedar's Sinai

• Mahmoud S Okasha, MD · Comprehensive Psychiatric Care, Norwich CT

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2010-06-30

Completion

2010-06-30

Countries

• United States

Study Locations