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Diclofenac add-on to Treatment as Usual for Suicidal Patients

This study is not yet open for participant recruitment.
Verified August 2011 by Region Skane
Sponsor:
Information provided by:
Region Skane
ClinicalTrials.gov Identifier:
NCT01413854
First received: August 9, 2011
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Depression Suicidal
 Drug: sugar pill
Drug: Diclofenac
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: "Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"

Resource links provided by NLM:

MedlinePlus related topics: Depression Suicide
U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Suicide Assessment Scale (differences in scores before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Montgomery Asberg Rating Scale (differences in scores before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: Yes ]
  • Barratt Impulsiveness Scale (differences in scores before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: Yes ]
  • Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: Yes ]
  • Montgomery Asberg Rating Scale (changes in concentration item before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: No ]
  • Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: No ]
  • Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment) [ Time Frame: four weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diclofenac Drug: Diclofenac
50 mg, two times daily (oral adm.) during four weeks
Other Name: 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 Name: One tablet two times daily during four weeks

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413854

Locations
Sweden
Psychiatry Skane
Lund, Sweden
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Åsa Westrin, MD, Phd Lund University
  More Information

No publications provided

Responsible Party: Åsa Westrin, Associate professor, Lund University
ClinicalTrials.gov Identifier: NCT01413854     History of Changes
Other Study ID Numbers: eudraCT number 2010-021024-10
Study First Received: August 9, 2011
Last Updated: August 10, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013