Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ziprasidone

Sertraline

Haloperidol

About this trial

This is an interventional treatment trial for Affective Disorders focused on measuring Psychotic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Southern California
Alexandria University
National Institute of Mental Health and Neuroscience

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ziprasidone

Sertraline/Haloperidol

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00340379

First Posted

June 20, 2006

Last Updated

August 15, 2014

Sponsor

Duke University

Collaborators

Pfizer, National Institute of Mental Health and Neuro Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT00340379

Brief Title

Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Official Title

A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Pfizer, National Institute of Mental Health and Neuro Sciences, India

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Affective Disorders

Keywords

Psychotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ziprasidone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sertraline/Haloperidol

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ziprasidone

Other Intervention Name(s)

Geodon

Intervention Description

Target dosage 120-160mg/day based on tolerance

Intervention Type

Drug

Intervention Name(s)

Sertraline

Other Intervention Name(s)

Zoloft

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Haloperidol

Other Intervention Name(s)

Haldol

Intervention Description

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

Primary Outcome Measure Information:

Title

21 Item Hamilton Depression Rating Scale

Description

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).

Time Frame

12 week

Title

Clinical Global Impression Improvement Scale

Description

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).

Time Frame

12 weeks

Title

Brief Psychiatric Rating Scale at 12 Weeks

Description

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.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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)

Overall Study Officials: