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Diclofenac add-on to Treatment as Usual for Suicidal Patients

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

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01413854
Enrollment
0
Registered
2011-08-10
Start date
2011-08-31
Completion date
2011-08-31
Last updated
2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Suicidal

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.

Interventions

DRUGsugar pill

One tablet two times daily during four weeks

DRUGDiclofenac

50 mg, two times daily (oral adm.) during four weeks

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Suicide Assessment Scale (differences in scores before and after treatment)four weeks of treatment

Secondary

MeasureTime frame
Barratt Impulsiveness Scale (differences in scores before and after treatment)four weeks of treatment
Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment)four weeks of treatment
Montgomery Asberg Rating Scale (differences in scores before and after treatment)four weeks of treatment
Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment)four weeks of treatment
Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment)four weeks of treatment
Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)four weeks of treatment

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026