Major Depressive DisorderPhase 2GeodonNCT00555997

A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder

A Phase 2 study testing Ziprasidone in people with Major Depressive Disorder, run by Massachusetts General Hospital at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study on the effectiveness, tolerability and safety of oral ziprasidone as monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD will be treated with either ziprasidone or placebo for 12 weeks. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Ziprasidone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 7 sitesUnited States
Study dates: Mar 2008to Jun 2010
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-65.
Written informed consent.
MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.

Who cannot join

Pregnant women.
Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.

Show all 20Show fewer

Patients who meet criteria for alcohol or substance dependence, active within the last month.
Any bipolar disorder (current or past).
Any psychotic disorder (current or past).
Psychotic features in the current episode or a history of psychotic features.
History of a seizure disorder.
Clinical or laboratory evidence of untreated hypothyroidism.
Patients requiring excluded medications (see table 1 for details).
Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
Any investigational psychotropic drug within the last 3 months.
Patients with significant cardiac conduction problems on screening electrocardiogram such as atrial fibrillation, atrial flutter, atrio-ventricular block, prolonged or abnormal QTc interval (i.e. QTc>450msec), or prolonged QRS interval.
Patients who have suffered a myocardial infarction within the past 12 months, with uncompensated heart failure, or a history of QTc prolongation.
Patients with abnormal serum potassium or magnesium levels upon screening.
Patients currently taking other drugs that prolong the QTc including dofetilide, sotalol, quinidine, class Ia antiarrhythmics, class III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron methylate, probucol or tacrolimus.
Patients who have failed to experience significant clinical improvement following 3 or more antidepressant trials of adequate duration (at least 6 weeks) and dose (minimal effective doses defined as: fluoxetine, paroxetine, citalopram 20mg; sertraline, fluvoxamine 50mg, escitalopram 10mg, paroxetine CR 25mg, venlafaxine 75mg, duloxetine 60mg, bupropion 150mg, 15mg of mirtazapine, trazodone or nefazodone 300mg).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Massachusetts General Hosptial
Boston, Massachusetts, 02114
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
Psychiatric Medicine Associates, L.L.C.
Chicago, Illinois, 60612
University of Connecticut Health Center
Farmington, Connecticut, 06030-6415
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360

Other trials in United States

About this study

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder

Hypothesis: There will be a statistically significant difference in the magnitude of response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be greater in the ziprasidone monotherapy group than in the placebo group.

Read the detailed description

Exploratory hypothesis 1: There will be a statistically significant difference in the percentage of responders in the two treatment groups; response rates will be significantly higher for the ziprasidone monotherapy compared to the placebo group.

Exploratory hypothesis 2: The change in 6-VAS-D scores during the trial will be highly correlated to the change in HAM-D-17 and QIDS-SR during the trial.

Conditions: Major Depressive Disorder
Being tested: Ziprasidone, Placebo
Keywords: Major Depressive Disorder, Major Depression, Depression, Geodon, Ziprasidone
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZiprasidoneDrug
Also called Geodon
20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
ZiprasidoneDrug
Also called Geodon
20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.
PlaceboDrug
0mg Placebo per day. "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo

Study groups in NCT00555997
Study group	Role	What they receive
1	Active comparator	Patients in group 1 will receive Ziprasidone for the full 12 weeks of the study. Receives: Drug: Ziprasidone
2	Active comparator	Patients in Group 2 will receive placebo for the first 6 weeks of the study, then will receive Ziprasidone for the last 6 weeks. Receives: Drug: Ziprasidone
3	Placebo comparator	Patients in Group 3 will receive placebo for the full 12 weeks of the study. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Rating Scale (HAM-D-17) Scores
Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.
Measured: 6 weeks

Secondary outcomes (2)

Responder/Non-responder
A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).
Measured: 6 weeks
Change in 6-VAS-D Scores During Each Phase.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jun 2010

First posted9 Nov 2007 (estimated)
Study startMar 2008
Primary completionJun 2010
Study completionJun 2010

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00555997
Sponsor's protocol ID: 2007-P-000623
Acronym: Geodon
Status last verified: Jun 2014
First submitted: 7 Nov 2007
Last updated: 3 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Papakostas GI, Vitolo OV, Ishak WW, Rapaport MH, Zajecka JM, Kinrys G, Mischoulon D, Lipkin SH, Hails KA, Abrams J, Ward SG, Meisner A, Schoenfeld DA, Shelton RC, Winokur A, Okasha MS, Bari MA, Fava M. A 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. J Clin Psychiatry. 2012 Dec;73(12):1541-7. doi: 10.4088/JCP.12m07670.
PubMed 23290327
Heo JY, Jeon HJ, Fava M, Mischoulon D, Baer L, Clain A, Doorley J, Pisoni A, Papakostas GI. Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial. J Psychiatr Res. 2015 Mar;62:56-61. doi: 10.1016/j.jpsychires.2015.01.007. Epub 2015 Jan 26.
PubMed 25659187

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder
ClinicalTrials.gov ID: NCT00555997
Acronym / sponsor ID: Geodon / 2007-P-000623
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, Major Depression, Depression, Geodon, Ziprasidone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Cambridge Health Alliance, University of Connecticut, Vanderbilt University, Psychiatric Medicine Associates, L.L.C., Cedars-Sinai Medical Center
Study start: Mar 2008
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 9 Nov 2007 (estimated)
Results: Posted 3 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Exploratory hypothesis 2: The change in 6-VAS-D scores during the trial will be highly correlated to the change in HAM-D-17 and QIDS-SR during the trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: ZiprasidonePatients in group 1 will receive Ziprasidone for the full 12 weeks of the study.
2	Active comparator	Drug: ZiprasidonePatients in Group 2 will receive placebo for the first 6 weeks of the study, then will receive Ziprasidone for the last 6 weeks.
3	Placebo comparator	Drug: PlaceboPatients in Group 3 will receive placebo for the full 12 weeks of the study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 18-65.
Written informed consent.
MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.

Key exclusion criteria (20 listed)

Pregnant women.
Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.

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: Geodon20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.	Drug	1
ZiprasidoneAlso: Geodon20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient.	Drug	2
Placebo0mg Placebo per day. "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo	Drug	3

Primary outcome

Hamilton Depression Rating Scale (HAM-D-17) Scores
Time frame: 6 weeks
Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.

2 secondary outcomes

Responder/Non-responder
Time frame: 6 weeks
Change in 6-VAS-D Scores During Each Phase.
Time frame: 6 weeks

Results and safety

Results posted to the registry on 3 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 Ziprasidone	29	17
Phase 1 Placebo	91	76
Phase 2 Ziprasidone	0	0
Phase 2 Placebo	0	0

Primary outcome: Hamilton Depression Rating Scale (HAM-D-17) Scores

Time frame: 6 weeks. Mean (Standard Deviation). Unit: points

Measure	Ziprasidone Phase I n = 29	Placebo Phase I n = 91	Ziprasidone Phase II n = 21	Placebo Phase II n = 25
Mean phase baseline score	20.1 (5.5)	19.9 (4.8)	14.7 (3.9)	15.6 (5.9)
Mean phase score reduction	-8.8 (7.3)	-7.1 (7.0)	-2.1 (5.2)	-4.3 (6.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 4 months. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziprasidone	0 of 80 (0%)	31 of 125 (24.8%)	Not reported
Placebo	1 of 125 (0.8%)	22 of 80 (27.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23290327Papakostas GI, Vitolo OV, Ishak WW, Rapaport MH, Zajecka JM, Kinrys G, Mischoulon D, Lipkin SH, Hails KA, Abrams J, Ward SG, Meisner A, Schoenfeld DA, Shelton RC, Winokur A, Okasha MS, Bari MA, Fava M. A 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. J Clin Psychiatry. 2012 Dec;73(12):1541-7. doi: 10.4088/JCP.12m07670.
Derived from this study: PubMed 25659187Heo JY, Jeon HJ, Fava M, Mischoulon D, Baer L, Clain A, Doorley J, Pisoni A, Papakostas GI. Efficacy of ziprasidone monotherapy in patients with anxious depression: a 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial. J Psychiatr Res. 2015 Mar;62:56-61. doi: 10.1016/j.jpsychires.2015.01.007. Epub 2015 Jan 26.
Depression Clinical and Research Program at MGHLink provided by the sponsor.

Related trials for Major Depressive Disorder

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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.

George I Papakostas, M.D. principal investigator

Massachusetts General Hospital

John M Zajecka, M.D. principal investigator

Psychiatric Medicine Associates, L.L.C.

Richard C Shelton, M.D. principal investigator

Vanderbilt University Medical Center

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ziprasidone in people with Major Depressive Disorder, run by Massachusetts General Hospital at 7 sites in United States.

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 4 inclusion and 20 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 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 3 Jul 2014). 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?

Hamilton Depression Rating Scale (HAM-D-17) Scores (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00555997, which also lists 2 linked publications.

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 3 Jul 2014.