NCT00226135

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

September 23, 2005

Last Update Submit

April 4, 2007

Conditions

Bipolar Disorder

Keywords

Bipolar disorderTreatmentLong-termLithiumLamotrigineRandomised Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

Interventions

lithium or lamotrigineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Psychiatric Hospital

Risskov, Risskov, 8240, Denmark

Location

Related Publications (1)

  • Hashimoto Y, Kotake K, Watanabe N, Fujiwara T, Sakamoto S. Lamotrigine in the maintenance treatment of bipolar disorder. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD013575. doi: 10.1002/14651858.CD013575.pub2.

    PMID: 34523118DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

LithiumLamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsTriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rasmus W Licht, MD, PhD

    Aarhus University Psychiatric Hospital, Risskov, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 26, 2005

Study Start

March 1, 2001

Study Completion

December 1, 2006

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations

DK(1)