NCT00340379

Brief Summary

The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2003

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
7 years until next milestone

Results Posted

Study results publicly available

June 4, 2013

Completed
Last Updated

August 19, 2014

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

June 20, 2006

Results QC Date

June 28, 2011

Last Update Submit

August 15, 2014

Conditions

Affective Disorders

Keywords

Psychotic

Outcome Measures

Primary Outcomes (3)

  • 21 Item Hamilton Depression Rating Scale

    The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).

    12 week

  • Clinical Global Impression Improvement Scale

    A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).

    12 weeks

  • Brief Psychiatric Rating Scale at 12 Weeks

    A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.

    12 weeks

Study Arms (2)

Ziprasidone

ACTIVE COMPARATOR

Subjects in this arm received ziprasidone with a placebo to maintain the blind

Drug: Ziprasidone

Sertraline/Haloperidol

ACTIVE COMPARATOR

Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.

Drug: SertralineDrug: Haloperidol

Interventions

ZiprasidoneDRUG

Target dosage 120-160mg/day based on tolerance

Also known as: Geodon
Ziprasidone
SertralineDRUG

Target dosage 150-200mg/day based on tolerance.

Also known as: Zoloft
Sertraline/Haloperidol
HaloperidolDRUG

Target dosage 6-8mg/day based on tolerance.

Also known as: Haldol
Sertraline/Haloperidol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, aged 18-70 years
  • If female, must state willingness to use medically accepted methods of birth control (if of reproductive age) and have negative pregnancy test
  • Ability to understand study procedures and provide written informed consent
  • A DSM-IV diagnosis of Major Depressive Disorder, with psychotic features, based on the Structured Clinical Interview for DSM-IV (SCID)
  • Hamilton Depression Rating Scale score (21-item HDRS) greater than or equal to 22

You may not qualify if:

  • A current or lifetime DSM-IV diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
  • A DSM-IV diagnosis of alcohol or substance abuse or dependence within 3 months of study entry
  • A QTc greater than 460 msec or an abnormal EKG (except minor abnormalities considered by the site investigator to be clinically insignificant)
  • A heart rate less than or equal to 50
  • A personal or family history of QTc
  • Any current or past history of syncope
  • Concurrent treatment with medications associated with prolongation of the QTc
  • Concurrent treatment with medications that may affect magnesium or potassium, such as diuretics
  • Any acute, unstable or serious medical illness (eg, AIDS, history of seizures, history of CVAs).
  • Baseline blood chemistries that are outside local reference ranges and which are felt clinically significant by the site investigator, or a potassium, magnesium or calcium level outside of local reference ranges or liver function tests that are greater than 20% above the upper limit of local reference ranges. If magnesium and/or potassium are below the lower limit of the local laboratory norm, they may be repeated and rechecked during the screening phase, and if within laboratory norms, the subjects may be included.
  • History of unstable cardiovascular disease
  • A significant risk of suicide in the judgement of the site investigator
  • A history of allergy or hypersensitivity to haloperidol, sertraline or ziprasidone
  • Any history of neuroleptic malignant syndrome
  • Treatment with sertraline or ziprasidone within 30 days of study entry
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Southern California

Los Angeles, California, 90033, United States

Location

Alexandria University

Alexandria, Egypt

Location

National Institute of Mental Health and Neuroscience

Bangalore, 560029, India

Location

MeSH Terms

Conditions

Mood DisordersMental Disorders

Interventions

ziprasidoneSertralineHaloperidol

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsButyrophenonesKetones

Results Point of Contact

Title
Frederick Cassidy
Organization
Duke University
cassi002@mc.duke.edu
919-575-7801

Study Officials

  • Frederick Cassidy, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • George Simpson, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Ranga Krishnan, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Sumant Khanna, MD

    National Institute of Mental Health and Neuroscience

    PRINCIPAL INVESTIGATOR

  • Adel Elsheshai, MD

    Alexandria University

    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
SPONSOR

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 21, 2006

Study Start

April 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

August 19, 2014

Results First Posted

June 4, 2013

Record last verified: 2012-02

Locations

IN(1)EG(1)US(1)