Diclofenac add-on to Treatment as Usual for Suicidal Patients

Phase 1

Withdrawn

• Conditions: Depression Suicidal
• Interventions: Drug: sugar pill; Drug: Diclofenac

• Registration Number: NCT01413854
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	sugar pill	-
diclofenac	Diclofenac	-

Primary Outcome Measures

Name	Time	Method
Suicide Assessment Scale (differences in scores before and after treatment)	four weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Rating 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
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
Barratt Impulsiveness Scale (differences in scores before and after treatment)	four weeks of treatment
Montgomery Asberg Rating Scale (changes in concentration item before and after treatment)	four weeks of treatment

Trial Locations

Locations (1)

Psychiatry Skane; 🇸🇪 Lund, Sweden