Status:
COMPLETED
Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression
Lead Sponsor:
University Health Network, Toronto
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or...
Detailed Description
The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or...
Eligibility Criteria
Inclusion
- 1\. Meets DSM-IV criteria for a diagnosis of Bipolar I disorder, most recent episode depression, or bipolar II disorder, most recent episode depression using the structured clinical interview for DSM-IV Axis 1 disorders 2. Subjects must have a Hamilton depression rating scale score of \>16. 3. Patients at visit 1 must have documented trials (levels must be obtained) of their mood stabilizer for at least 2 weeks 4. Subjects must be between the ages of 18-70, male or female 5. Treatment with oral antipsychotics, anticonvulsants or benzodiazepines prior to enrolment or during the study will be permitted, but not other antidepressants.
- 6\. Female patients of childbearing potential must be using a medically accepted means of contraception.
- 7\. Patient is judged by the investigator to be in generally good health 8. Education level and a degree of understanding is such that the patient can communicate effectively with the investigator.
- 9\. Patient must be capable of providing informed consent.
Exclusion
- 1\. Treatment with antidepressant medication within one day prior to visit 1 or during the protocol.
- 2\. Patients previously showing poor therapeutic response to venlafaxine XR or lamotrigine 3. Judged clinically to be at serious suicidal risk. 4. DSM-IV criteria for substance dependence (except nicotine or caffeine) within the past 30 days 5. Course of ECT (electroconvulsive therapy) in the preceding 4 weeks prior to visit 1 or during the protocol.
- 6\. Patients who suffer from a major neurological or medical illness. 7. Current diagnosis of schizophrenia or other psychotic disorders as defined in the DSM-IV 8. Uncorrected hypothyroidism or hyperthyroidism 9. Female patients who are either pregnant or nursing 10. Elevated thyroid stimulating hormone (TSH).
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00188643
Start Date
January 1 2002
End Date
January 1 2007
Last Update
February 9 2011
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8