Diclofenac add-on to Treatment as Usual for Suicidal Patients

January 8, 2019 updated by: Region Skane

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Psychiatry Skane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: diclofenac
Drug: Diclofenac
50 mg, two times daily (oral adm.) during four weeks
Other Names:
  • 50 mg, two times daily (oral adm.) during four weeks
PLACEBO_COMPARATOR: sugar pill
Drug: sugar pill
One tablet two times daily during four weeks
Other Names:
  • One tablet two times daily during four weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Åsa Westrin, MD, Phd, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (ESTIMATE)

August 10, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eudraCT number 2010-021024-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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