Diclofenac add-on to Treatment as Usual for Suicidal Patients

Study Overview
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Brief Summary
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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
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The study will start with a feasibility study including treatment of 10 patients with diclofenac.

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

Conditions
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Depression Suicidal

Intervention / Treatment
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* Drug: sugar pill
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diclofenac<br> | Drug: Diclofenac<br>* 50 mg, two times daily (oral adm.) during four weeks<br>* Other names: 50 mg, two times daily (oral adm.) during four weeks;|
| Placebo Comparator: sugar pill<br> | Drug: sugar pill<br>* One tablet two times daily during four weeks<br>* Other names: One tablet two times daily during four weeks;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Montgomery Asberg depression Ratin scale (changes in suicidality 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 | 
| 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 |