Diclofenac add-on to Treatment as Usual for Suicidal Patients

Region Skane

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Depression Suicidal

Treatments: Drug: Diclofenac; Drug: sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01413854

eudraCT number 2010-021024-10

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

diclofenac

Active Comparator group

Treatment:

Drug: Diclofenac

sugar pill

Placebo Comparator group

Treatment:

Drug: sugar pill