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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Depression is a medical condition characterized by feeling sad even when good things happen, having low energy and motivation, and sometimes even experiencing suicidal thoughts. Bipolar II Disorder is an illness in which periods of depression alternate with periods of abnormally elevated mood, energy and activity, referred to as hypomania. After Major Depressive Disorder, Bipolar II Disorder is the most common cause of depression. Unfortunately, antidepressant medications, used alone, do not work as well in treating Bipolar depression as they do in treating other kinds of depression. Lamotrigine is a medication which studies show is effective in treating Bipolar depression. The investigators will determine if lamotrigine works best to treat Bipolar II depression if it is used alone, or if it is taken with an antidepressant. In the first part of our investigation, people with Bipolar II depression who have not responded to an antidepressant will either add lamotrigine to their antidepressant, or will stop the antidepressant and take lamotrigine alone. They will see the study doctor for 6 visits over 8 weeks, and will answer questions about their depressive symptoms and their overall health. The purpose of this study phase is to determine which treatment works best to treat active Bipolar depression. In the second part of the study, people who have responded to their assigned treatment may continue to receive it for another 44 weeks. They will see the study doctor monthly, and will answer similar questions about their health. Participants will also receive a physical examination and get a blood test three times during the study. The purpose of the second phase is to ascertain which treatment is best at preventing relapses of depression. The investigators hypothesize that people who take Lamotrigine plus an antidepressant will recover from their depression more completely, have a longer period of wellness, and have better quality of life compared to those taking Lamotrigine alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Anticonvulsants; Antidepressive Agents; Lamotrigine

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.