Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Nordfjord Psychiatric Centre H. Lundbeck A/S |
---|---|
Information provided by: | Nordfjord Psychiatric Centre |
ClinicalTrials.gov Identifier: | NCT00464191 |
Funding: An investigator-initiated trial funded by H. Lundbeck AS.
Study design: Prospective, randomised, placebo-controlled parallell-group multicenter study.
Aim: To investigate efficacy and side effects (especially mood switches) of escitalopram,a selective serotonin reuptake inhibitor, in the acute and maintenance treatment of bipolar depression.
Hypotheses:
Patients: In- and outpatients receiving care in the specialised psychiatric services of Western Norway. The population is intended to be representative of the patients treated for bipolar depression in ordinary specialist care. Patients must have a MADRS score of at least 20 at baseline. Patients with ongoing sustance abuse or dependence, organic mental illness, and non-affective psychotic symptoms are excluded.
Medication: Escitalopram 10-20 mg daily or placebo in addition to mood stabilisers. The dose of mood stabilisers must have been constant for the last six weeks prior to randomisation.
Method: Phase 1 is a eight-week acute treatment trial with six clinical assessments. Patients treated with escitalopram who have not responded after eight weeks (defined by at least 50% reduction of MADRS score compared to baseline) leave the study. Placebo non-responders are treated openly with escitalopram and repeat phase 1. Reponders are re-randomised to 32 weeks of maintenance treatment (phase 2). Phase 2 has nine clinical assessments. Patients who develop hypomania, mania or depressive episodes (defined as episodes meeting DSM-IV criteria for Major Depressive Episode with MADRS scores of at least 20 points) leave the study in this phase. Patients leaving the study prematurely will be offered alternative treatment.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: escitalopram |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Escitalopram in Bipolar Depression: a Placebo-Controlled Study of Acute and Maintenance Treatment |
Estimated Enrollment: | 150 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2008 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Trond F Aarre, MD | +47 57 86 43 30 | trond.aarre@helse-forde.no |
Contact: Petter Bugge, MD | +47 57 86 43 30 | petter.bugge@helse-forde.no |
Norway | |
Nordfjord Psychiatric Centre | Recruiting |
Nordfjordeid, Norway, 6770 | |
Contact: Petter Bugge, MD +47 57 86 43 30 ext 43 42 petter.bugge@helse-forde.no | |
Contact: Trond F. Aarre, MD +47 57 86 43 30 ext 43 41 trond.aarre@helse-forde.no | |
Principal Investigator: Petter Bugge, MD |
Principal Investigator: | Trond F. Aarre, MD | Nordfjord Psychiatric Centre |
Study ID Numbers: | EudraCT 2005-004357-94, Lundbeck 10968, NPS 2005-1 |
Study First Received: | April 20, 2007 |
Last Updated: | April 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00464191 |
Health Authority: | Norway: Norwegian Medicines Agency |
bipolar depression SSRI escitalopram bipolar disorder |
antidepressant treatment trial RCT |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders Psychotic Disorders |
Dexetimide Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |