Diclofenac add-on to Treatment as Usual for Suicidal Patients

NCT ID: NCT01413854

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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

Conditions

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Depression Suicidal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

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

sugar pill

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type DRUG

One tablet two times daily during four weeks

Interventions

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sugar pill

One tablet two times daily during four weeks

Intervention Type DRUG

Diclofenac

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Åsa Westrin, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Psychiatry Skane

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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eudraCT number 2010-021024-10

Identifier Type: -

Identifier Source: org_study_id

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