Diclofenac add-on to Treatment as Usual for Suicidal Pati... | NCT01413854

Studies
Diclofenac add-on to Treatment as Usual for Suicidal Patients

NCT01413854

Sponsor

Region Skane

Status

Withdrawn

Last Update Posted

Jan 10, 2019Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Depression Suicidal

Interventions

sugar pill
Diclofenac

Countries

Sweden

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

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough recources.

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Aug 9, 2011

First Posted Date

Aug 10, 2011Estimated

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

Jan 8, 2019

Last Update Posted Date

Jan 10, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.

Detailed Description

The study will start with a feasibility study including treatment of 10 patients with diclofenac.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diclofenac	Active Comparator		Drug: Diclofenac
sugar pill	Placebo Comparator		Drug: sugar pill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sugar pill	Drug	One tablet two times daily during four weeks	sugar pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Suicide Assessment Scale (differences in scores before and after treatment)		four weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Montgomery Asberg Rating Scale (differences in scores before and after treatment)		four weeks of treatment
Barratt Impulsiveness Scale (differences in scores before and after treatment)		four weeks of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Depressive disorder
Montgomery Asberg Rating Scale Score more than 20 p.
Recent suicide attempt (Treated as inpatient due to a recent suicide attempt)
Informed consent
Competence to give informed consent

Exclusion Criteria:

Pregnancy
Breastfeeding
Serious somatic disease e.g. serious heart, vascular, hepatic, kidney, pulmonary, intestinal, endocrine, haematological or neurological diseases
Ongoing substance abuse
Schizophrenia or other psychotic disorders
Ongoing psychosis
Risk factors for cardiovascular events
Ulcer or gastrointestinal bleeding
Ongoing Electroconvulsive therapy
Previous allergic reaction to NSAID, acetylsalicylic acid, sulfonamides or the diclofenac or sugar pill content
Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
Ongoing treatment with warfarin or other anticoagulants
Ongoing treatment with ACE inhibitors or angiotensin II antagonists Ongoing treatment with drugs known to effect the immune system Ongoing treatment with rifampicin, carbamazepine or barbiturates

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Åsa Westrin, MD, Phd	Lund University	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D000073893	Sugars
D004008	Diclofenac
D053607	Adrenomedullin

Ancestor Terms

ID	Term
D002241	Carbohydrates
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided