Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder - Full Text View

Sponsor:	University of Aarhus
Collaborators:	Stanley Medical Research Institute GlaxoSmithKline
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00226135

Purpose

The purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.

Condition	Intervention	Phase
Bipolar Disorder	Drug: lithium or lamotrigine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Lamotrigine Versus Lithium in Subjects With Bipolar Affective Disorders - a Randomised Study of Prophylactic Effect

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Time to a new mood episode after having succeeded the first 6 month of treatment and reached monotherapy with study drug at that point. New episode defined as symptoms requiring treatment or admission (or suicide).

Secondary Outcome Measures:

1: number of patients (ITT population)that completed first 6 months and achieved monotherapy at that time.
2: Number of patients with reported AE (type specified)
3: Number of patients with an endpoint other than censoring (among populations under observation for ½ year, 1 year, 1½ years, 2 years, and 2½ years)
4:The primary end point but selected to patients under observations for 1½ and 2½ years
5: Number of endpoint (other than censoring)among patients reaching 6 months and monotherapy at that time, per person-time(testing for inter-group balance with respect to background variables)

Estimated Enrollment:	150
Study Start Date:	March 2001
Study Completion Date:	December 2006

Detailed Description:

Bipolar disorder is a recurrent lifelong illness. Lithium is still the drug of first choice in the prophylactic treatment. However, lithium’s side effects are considerable. Thus the interest in developing alternatives to lithium has increased, and various antiepileptic drugs have been studied. Among these, lamotrigine, which generally is well tolerated, has been evaluated in industry generated trials. However, for various reasons, the generalisability of the results from these studies is limited. Also the follow-up time is limited. This study is a pragmatic effectiveness study, overcoming some of these limitations, and comparing lamotrigine with that of lithium in terms of their potentials for preventing new episodes in patients with bipolar disorder.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Age above 18
Inclusion is preceded by an affective episode requiring hospitalisation or outpatient drug treatment (index episode) which can be a manic episode (ICD-10 research criteria), a depressive episode of at least moderate degree (ICD-10 research criteria) or a mixed manic state (manic episode with at least additional three ICD-10 depressive symptoms except for difficulties with concentration or thinking, agitation or dyssomnia). The episode can be with or without psychotic symptoms including Schneiderian first-rank symptoms or bizarre delusions as long as the psychotic symptoms do not occur outside the affective episode.
No more than 12 months may pass between the onset of the index episode (or admission if that is the case)and date of randomisation (in order to ensure a current risk of relapse as well as reliable psychopathological information).
Besides the index episode, at least one previous episode must have occurred within the last five years which meets the criteria mentioned in point number two above. This episode may not necessarily have led to hospitalisation. Two episodes are separated by at least two months without significant symptoms or change in polarity (depression to mania/mixed mania or vice versa).
At least one manic episode (or mixed manic episode) within the last 5 years.

Exclusion criteria:

Contraindications to the protocol drugs.
Severe somatic disease, e.g. epilepsy, which may interfere with study treatment or effect evaluation.
Pregnancy (or risk of pregnancy).
Subject has prior to randomization received prophylactic treatment with lithium or lamotrigine conducted adequately in the sense of sufficient time and dose and ensuring compliance, and experienced a definite lack of prophylactic effect
An ICD-10 diagnosis of abuse within the last year with a subsequent risk of protocol violation. Therefore, subjects with a secondary abuse can often be included in the study.
Anticipated protocol violation for other reasons.
No written informed consent from the subject can be obtained.
The subject has previously been randomised in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226135

Locations

Denmark
Aarhus University Psychiatric Hospital
Risskov, Denmark, 8240

Sponsors and Collaborators

University of Aarhus

Stanley Medical Research Institute

GlaxoSmithKline

Investigators

Principal Investigator:

Rasmus W Licht, MD, PhD

Aarhus University Psychiatric Hospital, Risskov, Denmark

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00226135 History of Changes
Other Study ID Numbers:	2612-1400, 98-rc-316
Study First Received:	September 23, 2005
Last Updated:	April 4, 2007
Health Authority:	Denmark: National Board of Health

Keywords provided by University of Aarhus:

Bipolar disorder
Treatment
Long-term

Lithium
Lamotrigine
Randomised Clinical Trial

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium
Lithium Carbonate
Lamotrigine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012