Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression
Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Venlafaxine and Lamotrigine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s):
Roger McIntyre, MD,FRCPC, Principal Investigator, Affiliation: University Health Network, Toronto
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 Bipolar II disorder. Efficacy of therapy will be evaluated using
improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions
on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also
would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to
mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well
as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and
lamotrigine.
Clinical Details
Official title: Double-Blind, Acute Depression Study Comparing Venlafaxine XR and Lamotrigine When Added to Mood Stabilizer in the Treatment of Bipolar Depression
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Hamilton Depression Rating Scale, 21 item
Secondary outcome: Young Mania Rating Scale (YMRS)Montgomery Asberg Depression Rating Scale (MADRS) Clinical Global Impression (CGI-I, CGI-S) Quality of Life Enjoyment Global Assessment of Functioning
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 Bipolar II disorder. Efficacy of therapy will be evaluated using
improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions
on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also
would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to
mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well
as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and
lamotrigine.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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).
Locations and Contacts
Toronto Western Hospital, Toronto, Ontario M5T2S8, Canada
Additional Information
Starting date: January 2002
Ending date: January 2007
Last updated: April 18, 2007
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