Study of Pharmacotherapy of Psychotic Depression (STOP-PD)
This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00056472
First received: March 14, 2003
Last updated: August 20, 2008
Last verified: August 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 14, 2003 | ||||
| Last Updated Date | August 20, 2008 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Remission of depression (Hamilton Depression Scale) and psychosis (Schedule for Affective Disorders in Schizophrenia - delusional item) during the course of the trial [ Time Frame: Weeks 1-6, 8, 10, 12 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00056472 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
CGI-S scores over the course of the trial [ Time Frame: Weeks 1-6, 8,10,12 ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Pharmacotherapy of Psychotic Depression | ||||
| Official Title ICMJE | Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression | ||||
| Brief Summary | This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression. |
||||
| Detailed Description | Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience not only the standard symptoms of depression, but also hallucinations and delusions. They also often become paranoid, believe that their thoughts are not their own, or think that others can hear their thoughts. This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression. The study will also evaluate the difference in treatment response of young adults versus geriatric patients. This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Major Depression With Psychotic Features | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 259 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00056472 | ||||
| Other Study ID Numbers ICMJE | U01 MH62624, DATR A4-GPX, U01 MH62565, U01 MH62518, U01 MH62446 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Barnett Meyers, M.D., Weill Medical College of Cornell University | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | August 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||