Ziprasidone and Sertraline in PTSD | NCT00248261

Studies
Ziprasidone and Sertraline in PTSD

NCT00248261

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Terminated

Last Update Posted

Feb 25, 2020Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Post-traumatic Stress Disorder

Interventions

ziprasidone, sertraline

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NRA1280017

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

High rate of early drop-outs

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Aug 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 2, 2005

First Submission Date that Met QC Criteria

Nov 2, 2005

First Posted Date

Nov 3, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2020

Last Update Posted Date

Feb 25, 2020Actual

Description Module

Brief Summary

Serotonin re-uptake inhibitors, such as sertraline, are the medication of choice in post-traumatic stress disorder. However, it takes several weeks before they ameliorate symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.

Detailed Description

A current problem in the pharmacotherapy of PTSD is that the medication of choice, serotonin re-uptake inhibitors, take several weeks before they show considerable effects on PTSD symptoms. Addition of typical neuroleptics, such as ziprasidone, offers a potential strategy to bring about a faster symptomatic relief, because they display anxiolytic properties without the risk of dependence. Therefore, in addition to standard sertraline therapy (at least 8 weeks), we will give ziprasidone vs. placebo over the first four weeks in a double-blind randomized design.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Name	Type	Description	Arm Group Labels	Other Names
ziprasidone, sertraline	Drug

Measure	Description	Time Frame
Post-Traumatic Diagnostic Scale (PDS)		56 days

Measure	Description	Time Frame
Beck Depression Inventory (BDI)		56 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Post-Traumatic Stress Disorder

Exclusion Criteria:

Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

PTSD patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael B Kellner, MD, PhD	UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UKE, Dept. of Psychiatry and Psychotherapy		Hamburg		2ß246	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20631571	Result	Kellner M, Muhtz C, Wiedemann K. Primary add-on of ziprasidone in sertraline treatment of posttraumatic stress disorder: lessons from a stopped trial? J Clin Psychopharmacol. 2010 Aug;30(4):471-3. doi: 10.1097/JCP.0b013e3181e79600. No abstract available.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes