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Diclofenac add-on to Treatment as Usual for Suicidal Patients

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ClinicalTrials.gov Identifier: NCT01413854
Recruitment Status : Unknown
Verified August 2011 by Region Skane.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2011
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Depression Suicidal Drug: sugar pill Drug: Diclofenac Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: "Antiinflammatoriska läkemedels Effekt för Att Minska Suicidalitet Hos Deprimerade Patienter Som Nyligen Har Gjort självmordsförsök"
Study Start Date : August 2011
Estimated Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Suicide Assessment Scale (differences in scores before and after treatment) [ Time Frame: four weeks of treatment ]

Secondary Outcome Measures :
  1. Montgomery Asberg Rating Scale (differences in scores before and after treatment) [ Time Frame: four weeks of treatment ]
  2. Barratt Impulsiveness Scale (differences in scores before and after treatment) [ Time Frame: four weeks of treatment ]
  3. Montgomery Asberg depression Ratin scale (changes in suicidality item before and after treatment) [ Time Frame: four weeks of treatment ]
  4. Montgomery Asberg Rating Scale (changes in concentration item before and after treatment) [ Time Frame: four weeks of treatment ]
  5. Comprehensive Psychopathological Rating Scale (changes in aggressive feelings item before and after treatment) [ Time Frame: four weeks of treatment ]
  6. Comprehensive Psychopthological Rating Scale (changes in fatigue item before and after treatment) [ Time Frame: four weeks of treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413854


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

Responsible Party: Åsa Westrin, Associate professor, Lund University
ClinicalTrials.gov Identifier: NCT01413854     History of Changes
Other Study ID Numbers: eudraCT number 2010-021024-10
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action