Diclofenac add-on to Treatment as Usual for Suicidal Patients

Depression Suicidal Clinical Trial

Official title:

"Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01413854
• Other study ID #: eudraCT number 2010-021024-10
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression Suicidal

Intervention

Drug:
• sugar pill
One tablet two times daily during four weeks
• Diclofenac
50 mg, two times daily (oral adm.) during four weeks

Locations

Country	Name	City	State
Sweden	Psychiatry Skane	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicide Assessment Scale (differences in scores before and after treatment)		four weeks of treatment
Secondary	Montgomery Asberg Rating Scale (differences in scores before and after treatment)		four weeks of treatment
Secondary	Barratt Impulsiveness Scale (differences in scores before and after treatment)		four weeks of treatment
Secondary	Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment)		four weeks of treatment
Secondary	Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)		four weeks of treatment
Secondary	Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment)		four weeks of treatment
Secondary	Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment)		four weeks of treatment