Diclofenac add-on to Treatment as Usual for Suicidal Patients

NCT01413854 | Withdrawn Phase 1 DMC

• 1 other identifier: eudraCT number 2010-021024-10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Suicidal

Outcome Measures

Primary Outcomes (1)

• Suicide Assessment Scale (differences in scores before and after treatment)

  four weeks of treatment

Secondary Outcomes (6)

• Montgomery Asberg Rating Scale (differences in scores before and after treatment)

  four weeks of treatment

• Barratt Impulsiveness 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

• Montgomery Asberg Rating Scale (changes in concentration 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

Study Arms (2)

diclofenac

ACTIVE COMPARATOR

Drug: Diclofenac

sugar pill

PLACEBO COMPARATOR

Drug: sugar pill

Interventions

sugar pill DRUG

One tablet two times daily during four weeks

Also known as: One tablet two times daily during four weeks

sugar pill

Diclofenac DRUG

50 mg, two times daily (oral adm.) during four weeks

Also known as: 50 mg, two times daily (oral adm.) during four weeks

diclofenac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Psychiatry Skane

Lund, Sweden

Location

MeSH Terms

Interventions

Sugars; Diclofenac; Adrenomedullin

Intervention Hierarchy (Ancestors)

Carbohydrates; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Åsa Westrin, MD, Phd

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

SE (1)