Ziprasidone Augmentation of SSRIs for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs

NCT00633399 | Completed Phase 2 Results DMC

• 1 other identifier: 2007-P-002361
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see if adding the study drug, ziprasidone, to an antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are studying the drug's effectiveness in treating depression, as well as its safety when it is added to another drug. Hypothesis A: There will be a difference in the percentage of responders in the two treatment conditions during phase 2; response rates will be higher for the ziprasidone group.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Major Depression; Depression; Geodon; Ziprasidone; SSRI Augmentation; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2

  The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.

  8 Weeks

Secondary Outcomes (2)

• Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.

  8 weeks

• Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2. If they are in remission following phase two, and decide to enter phase three, they will continue on Ziprasidone for 12 months.

Drug: Ziprasidone

2

PLACEBO COMPARATOR

Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2. If they are in remission following phase two, and decide to enter phase three, they will continue on Placebo for 12 months.

Drug: Placebo

Interventions

Ziprasidone DRUG

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.

Also known as: Geodon

1

Placebo DRUG

0mg Placebo per day (1-4 tablets per day). "Dose increases" and "dose decreases" may occur, but patient will remain at 0mg placebo.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Men or women, 18-65 years of age.
• MDD, current, according to DSM-IV criteria and as diagnosed by the SCID- I/P during the screen and baseline visit of phase 1.
• A HAM-D-17 score \> 14 during the screen and baseline visit of phase 1.

You may not qualify if:

• Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine
• Device, tubal ligation, or partner with vasectomy).
• Serious suicide or homicide risk, as assessed by evaluating clinician.
• Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
• History of multiple adverse drug reactions or allergy to the study drug.
• The following DSM-IV diagnoses: substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past).
• Patients requiring excluded medications (see appendix 1 for details).
• Psychotic features in the current episode or a history of psychotic features.
• Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
• Any investigational psychotropic drug within the last 3 months.
• Have failed more than 3 adequate antidepressant trials during the current MDE. Some examples of adequate dosage of an antidepressant trial include either \> 150 mg of imipramine (or its tricyclic equivalent), \> 60 mg of phenelzine (or its monoamine oxidase inhibitor equivalent), \> 20 mg of fluoxetine (or its SSRI-equivalent), \> 150mg of bupropion, \> 300mg of trazodone (or nefazodone), \>75 mg of venlafaxine, \>60mg of duloxetine, or \> 15mg of mirtazapine. A trial of adequate duration was defined as one during which the patient was on any given antidepressant at an adequate dose for a minimum of 6 weeks.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Massachusetts General Hospital- Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Mischoulon D, Shelton RC, Baer L, Bobo WV, Curren L, Fava M, Papakostas GI. Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Cardiac, Endocrine, Metabolic, and Motoric Effects in a Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2017 Apr;78(4):449-455. doi: 10.4088/JCP.15m10426.

  PMID: 27835715 DERIVED

• Ionescu DF, Shelton RC, Baer L, Meade KH, Swee MB, Fava M, Papakostas GI. Ziprasidone augmentation for anxious depression. Int Clin Psychopharmacol. 2016 Nov;31(6):341-6. doi: 10.1097/YIC.0000000000000133.

  PMID: 27306192 DERIVED

• Papakostas GI, Fava M, Baer L, Swee MB, Jaeger A, Bobo WV, Shelton RC. Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study. Am J Psychiatry. 2015 Dec;172(12):1251-8. doi: 10.1176/appi.ajp.2015.14101251. Epub 2015 Jun 18.

  PMID: 26085041 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder, Treatment-Resistant

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: George I Papakostas, M.D. - Scientific Director
• Organization: Massachusetts General Hospital CNTI

gpapakostas@partners.org

6177266697

Study Officials

• George I Papakostas, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-06

Locations

US (2)