Depression Suicidal | Diclofenac add-on to Treatment as Usual for Suicidal Patients
Depression Suicidal research study
What is the primary objective of this study?
The purpose of this study is to determine whether diclofenac is effective in the treatment of depressed patients with a recent suicide attempt.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:sugar pillOne tablet two times daily during four weeks
Drug:Diclofenac50 mg, two times daily (oral adm.) during four weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: August 2011
Phase: Phase 1/Phase 2
Primary Outcome: Suicide Assessment Scale (differences in scores before and after treatment)
Secondary Outcome: Montgomery Asberg Rating Scale (differences in scores before and after treatment)
Study sponsors, principal investigator, and references
Principal Investigator: Åsa Westrin, MD, Phd
Lead Sponsor: Region Skane