Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00475137
• Date of registration: 15/05/2007
• Primary sponsor: University of British Columbia
• Public title: Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression
• Scientific title: A Randomized, Single-Blind Comparison of Lamotrigine Add-on Versus Switch to Lamotrigine Monotherapy in the Treatment of Bipolar II Depression Unresponsive to Antidepressant Treatment
• Date of first enrolment: December 2007
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00475137
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Nazlin Walji

• Name: Nazlin Walji

• Name: Wetid Pratoomsri, Dr.
• Affiliation: Chachoengsao Hospital Thailand

• Name: Kyooseob Ha, Dr.
• Affiliation: Seoul National University Bundang Hospital

• Name: David Bond, MD
• Affiliation: University of British Columbia

• Name: Edwin Tam, MD
• Affiliation: University of British Columbia

• Name: Lakshmi Yatham, MD
• Affiliation: University of British Columbia

• Name: Mauricio Kunz, Dr.
• Affiliation: University of British Columbia

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects who meet all of the following criteria are eligible to participate in this trial:

1. Males or females, inpatients or outpatients, aged 17 to 70 years inclusive.

2. Diagnosis of Bipolar II Disorder, current episode depressed, without psychotic
features. Specifically, patients must have experienced at least one previous
episode of hypomania lasting at least 2 days, and no previous manic episodes.

3. The current episode of depression has a duration of at least 6 weeks.

4. Montgomery-Asberg Depression Rating Scale score of at least 18.

5. If female and of child-bearing age, must be using a reliable method of birth control.
Reliable methods of birth control include: oral contraceptive pill or patch or
surgically implanted device; intra-uterine device (IUD); tubal ligation; barrier
device such as diaphragm or condom plus spermicidal jelly or foam; or abstinence.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible to participate in the
trial:

1. Manic or hypomanic symptoms, defined as a YMRS score of 16 or greater.

2. Treatment with ECT or a depot antipsychotic medication within eight weeks prior to
enrolment; or treatment with an experimental drug within 30 days prior to enrolment.

3. Known lack of response to, or intolerance for, Lamotrigine. Lack of response is
defined as failure of depressive symptoms to improve after a trial of an acceptable
dose of medication, ie. 100 mg daily or greater of Lamotrigine for at least four
weeks.

4. Depressive symptoms secondary to substance use or a general medical condition, in the
opinion of the investigator.

5. Diagnosis of an anxiety disorder, including Generalized Anxiety Disorder, Social
Anxiety Disorder, Panic Disorder, Agoraphobia, Obsessive Compulsive Disorder,
Specific Phobia, Post-Traumatic Stress Disorder, or Acute Stress Disorder, which was
the primary focus of clinical attention in the year preceding enrolment.

6. Diagnosis of Schizophrenia, Schizoaffective Disorder, or Delusional Disorder.

7. Substance dependence within one month of enrolment, except for dependence in full
remission, and except for caffeine or nicotine dependence, as defined by the
DSM-IV-TR.

8. Diagnosis of Borderline Personality Disorder, Narcissistic Personality Disorder,
Histrionic Personality Disorder, or Antisocial Personality Disorder, which was the
primary focus of clinical attention in the year preceding enrolment.

9. Significant risk of harm to self or others, in the opinion of the investigator.

10. Use of any cytochrome P450 inducer or inhibitor within five half-lives prior to
enrolment.

11. Pregnancy or lactation in female subjects.

12. Unstable or inadequately treated medical illness, as judged by the investigator.

13. Liver function tests (AST and ALT) three times the upper limit of normal.

14. Glomerular Filtration Rate (GFR) of less than 60 mL/min per 1.73m2

15. A history of significant cardiac conduction abnormalities, as determined by the
investigator.



Age minimum: 17 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bipolar II Depression

Intervention(s)

Drug: Lamotrigine

Drug: Lamotrigine plus plus antidepressant medication subjects were prescribed prior to study entry

Primary Outcome(s)

Efficacy of Lamotrigine monotherapy versus Lamotrigine plus antidepressant in the acute and maintenance treatment of Bipolar II depression as evidence by decrease in Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to endpoint. [Time Frame: 8 weeks]

Secondary Outcome(s)

Rates of response to treatment and remission in both treatment arms maintenance efficacy of treatments as evidenced by relapse rates. Rates of treatment associated mania or hypomania as evidenced by increased score on the Young Mania Rating Scale (YMRS). [Time Frame: 44 weeks]

Secondary ID(s)

H06-03732

Source(s) of Monetary Support

Please refer to primary and secondary sponsors