Affective DisordersPhase 2/3NCT00340379
Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
A Phase 2/3 study testing Ziprasidone, Sertraline and Haloperidol in people with Affective Disorders, run by Duke University at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Affective Disorders
- What is being tested?
- Ziprasidone, Sertraline and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2003to Aug 2005
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Southern California
Los Angeles, California, 90033
India1 site
National Institute of Mental Health and Neuroscience
Bangalore, 560029
About this study
Official title: A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol
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.
Read the 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.
- Conditions
- Affective Disorders
- Being tested
- Ziprasidone, Sertraline, Haloperidol
- Keywords
- Psychotic
- Medical subject headings
- Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
Also called Geodon
Target dosage 120-160mg/day based on tolerance
SertralineDrug
Also called Zoloft
Target dosage 150-200mg/day based on tolerance.
HaloperidolDrug
Also called Haldol
Target dosage 6-8mg/day based on tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone | Active comparator | Subjects in this arm received ziprasidone with a placebo to maintain the blind Receives: 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. Receives: Drug: Sertraline; Drug: Haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startApr 2003
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Affective DisordersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Institute of Mental Health and Neuro Sciences, India
- Responsible party
- Sponsor
- Investigators
- Frederick Cassidy, MD, Principal investigator, Duke UniversityGeorge Simpson, MD, Principal investigator, University of Southern CaliforniaRanga Krishnan, MD, Principal investigator, Duke UniversitySumant Khanna, MD, Principal investigator, National Institute of Mental Health and NeuroscienceAdel Elsheshai, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340379
- Sponsor's protocol ID
- Pro00008437
- Other IDs
- 3846-05-6R2
- Status last verified
- Feb 2012
- First submitted
- 20 Jun 2006
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol
- ClinicalTrials.gov ID
- NCT00340379
- Acronym / sponsor ID
- Pro00008437
- Conditions
- Affective Disorders
- Keywords
- Psychotic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer, National Institute of Mental Health and Neuro Sciences, India
- Study start
- Apr 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Posted 4 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone | Active comparator | Drug: ZiprasidoneSubjects in this arm received ziprasidone with a placebo to maintain the blind |
| Sertraline/Haloperidol | Active comparator | Drug: Sertraline, Drug: HaloperidolSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiprasidoneAlso: GeodonTarget dosage 120-160mg/day based on tolerance | Drug | Ziprasidone |
| SertralineAlso: ZoloftTarget dosage 150-200mg/day based on tolerance. | Drug | Sertraline/Haloperidol |
| HaloperidolAlso: HaldolTarget dosage 6-8mg/day based on tolerance. | Drug | Sertraline/Haloperidol |
Primary outcome
21 Item Hamilton Depression Rating Scale
Time frame: 12 week
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Cassidy, MD principal investigator
Duke University
George Simpson, MD principal investigator
University of Southern California
Ranga Krishnan, MD principal investigator
Duke University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ziprasidone, Sertraline and Haloperidol in people with Affective Disorders, run by Duke University at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Egypt, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
21 Item Hamilton Depression Rating Scale (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.