Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

This study has been completed.
Sponsor:
Collaborators:
Pfizer
National Institute of Mental Health and Neuro Sciences, India
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00340379
First received: June 20, 2006
Last updated: July 11, 2014
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Affective Disorders
Drug: Ziprasidone
Drug: Sertraline
Drug: Haloperidol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 21 Item Hamilton Depression Rating Scale [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    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).

  • Clinical Global Impression Improvement Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Brief Psychiatric Rating Scale at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 72
Study Start Date: April 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ziprasidone
Subjects in this arm received ziprasidone with a placebo to maintain the blind
Drug: Ziprasidone
Target dosage 120-160mg/day based on tolerance
Other Name: Geodon
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340379

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Egypt
Alexandria University
Alexandria, Egypt
India
National Institute of Mental Health and Neuroscience
Bangalore, India, 560029
Sponsors and Collaborators
Duke University
Pfizer
National Institute of Mental Health and Neuro Sciences, India
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00340379     History of Changes
Other Study ID Numbers: Pro00008437, 3846-05-6R2
Study First Received: June 20, 2006
Results First Received: June 28, 2011
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board
Egypt: Institutional Review Board
India: Institutional Review Board

Keywords provided by Duke University:
Psychotic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Haloperidol
Haloperidol decanoate
Ziprasidone
Sertraline
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antidepressive Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014