Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

NCT00340379

Last updated date
Study Location
University of Southern California
Los Angeles, California, 90033, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Affective Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


- History of recent treatment with any long acting psychotropic medications


- Treatment with a MAO-inhibitor within 14 days of study entry


- Treatment with an investigational drug within 30 days of study entry


- Current use of carbamazepine, nefazodone, ketoconazole or erythromycin


- A positive pregnancy test


- A positive drug screen unless attributable to a prescribed medication (e.g.
benzodiazepines)

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Affective DisordersZiprasidone vs. Sertraline/Haloperidol in Psychotic Depression
NCT00340379
  1. Los Angeles, California
  2. Alexandria,
  3. Bangalore,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
Official Title  ICMJE A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol
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.
Detailed Description Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Affective Disorders
Intervention  ICMJE
  • Drug: Ziprasidone
    Target dosage 120-160mg/day based on tolerance
    Other Name: Geodon
  • Drug: Sertraline
    Target dosage 150-200mg/day based on tolerance.
    Other Name: Zoloft
  • Drug: Haloperidol
    Target dosage 6-8mg/day based on tolerance.
    Other Name: Haldol
Study Arms  ICMJE
  • Active Comparator: Ziprasidone
    Subjects in this arm received ziprasidone with a placebo to maintain the blind
    Intervention: Drug: Ziprasidone
  • Active Comparator: Sertraline/Haloperidol
    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.
    Interventions:
    • Drug: Sertraline
    • Drug: Haloperidol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2009)
72
Original Enrollment  ICMJE
 (submitted: June 20, 2006)
75
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of recent treatment with any long acting psychotropic medications
  • Treatment with a MAO-inhibitor within 14 days of study entry
  • Treatment with an investigational drug within 30 days of study entry
  • Current use of carbamazepine, nefazodone, ketoconazole or erythromycin
  • A positive pregnancy test
  • A positive drug screen unless attributable to a prescribed medication (e.g. benzodiazepines)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00340379
Other Study ID Numbers  ICMJE Pro00008437
3846-05-6R2 ( Other Identifier: Duke legacy protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Pfizer
  • National Institute of Mental Health and Neuro Sciences, India
Investigators  ICMJE
Principal Investigator:Frederick Cassidy, MDDuke University
Principal Investigator:George Simpson, MDUniversity of Southern California
Principal Investigator:Ranga Krishnan, MDDuke University
Principal Investigator:Sumant Khanna, MDNational Institute of Mental Health and Neuroscience
Principal Investigator:Adel Elsheshai, MDAlexandria University
PRS Account Duke University
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP