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Trial record 12 of 215 for:    Lamotrigine

Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine

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ClinicalTrials.gov Identifier: NCT02989727
Recruitment Status : Completed
First Posted : December 12, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Evyn Peters, University of Saskatchewan

Brief Summary:
The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).

Condition or disease Intervention/treatment Phase
Depression Bipolar Disorder Bipolar Depression Melancholia Lamotrigine Drug: Lamotrigine Drug: Placebos Phase 4

Detailed Description:

Patients suffering from depression with melancholic symptoms (i.e., anhedonia, flat affect, diurnal mood variation, terminal insomnia, psychomotor disturbances, decreased weight/appetite, and excessive guilt) respond better to certain antidepressants. Melancholic symptoms also occur in bipolar depression, although they have received less research. Lamotrigine has been shown to alter some of the biological processes that are known to occur in melancholic depression. The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression.

This study will re-analyze data from a previous 8-week, randomized, placebo-controlled trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677). The original study data was made available by GlaxoSmithKline as part of an initiative to make clinical trials data available for research use. Access was applied for via https://www.clinicalstudydatarequest.com.

The analysis strategy will be comparable to the original study, although the investigators will first classify participants as suffering from either melancholic or non-melancholic depression. The diagnosis of melancholic depression was established according to baseline responses to the Hamilton Depression Rating Scale (HAMD-17) and the Montgomery-Åsberg Depression Rating Scale (MADRS), according to the DSM-IV-TR diagnostic criteria. HAMD-17 and MADRS change scores will be compared between the treatment and placebo groups using Analysis of Variance (ANOVA). Both ANOVA models will include a test for an interaction between treatment group (lamotrigine vs. placebo) and melancholic depression (melancholic depression vs. non-melancholic depression). To handle missing data, each ANOVA model will be computed with only complete-case data first and subsequently using inverse probability weights that account for the probability of drop out. Inverse probability weights will be created based on covariates that predict missing responses. HAMD-17 and MADRS response rates between the treatment and placebo groups will be evaluated with a Cox proportional hazard regression analysis. There will be two separate analyses, one including participants with melancholic depression, and one including participants with non-melancholic depression. Statistical models will also adjust for baseline depression severity, if participants with melancholic depression are found to have more severe depressive symptoms at baseline.

Given the delay between antidepressant initiation and response, trial-and-error prescribing is an inevitably lengthy process. The investigators hope the results of this study will enable more timely and effective treatment for patients with bipolar depression.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine: Results From an 8-week, Multicenter, Double-blind, Placebo-controlled Trial
Study Start Date : November 2003
Actual Primary Completion Date : August 2005
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
Experimental: Lamotrigine - melancholic depression
Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.
Drug: Lamotrigine
Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.
Other Name: Lamictal

Placebo Comparator: Placebo - melancholic depression
Participants with melancholic depression who were randomly assigned to receive a placebo comparator.
Drug: Placebos
Placebo tablets
Other Name: Placebo

Experimental: Lamotrigine - nonmelancholic depression
Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.
Drug: Lamotrigine
Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.
Other Name: Lamictal

Placebo Comparator: Placebo - nonmelancholic depression
Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.
Drug: Placebos
Placebo tablets
Other Name: Placebo




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores [ Time Frame: Eight weeks ]

    Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores.

    Lower scores indicate greater improvement of depressive symptoms.


  2. Hamilton Depression Rating Scale (HAMD-17) Change Scores [ Time Frame: Eight weeks ]

    Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores.

    Lower scores indicate greater improvement of depressive symptoms.


  3. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Eight weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  4. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Seven weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  5. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Six weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  6. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Five weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  7. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Four weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  8. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Three weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  9. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Two weeks ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  10. Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: One week ]
    Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.

  11. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Eight weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  12. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Seven weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  13. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Six weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  14. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Five weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  15. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Four weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  16. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Three weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  17. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Two weeks ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.

  18. Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: One week ]
    Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must provide written and informed consent.
  2. Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.
  3. For females, be of non-childbearing potential, or of childbearing potential with a negative pregnancy test at screening and agrees to one of (a) abstinence from sex two weeks prior and five days after drug continuation/discontinuation, (b) personal or partner sterilization, (c) one method of hormonal contraception, or (d) two barrier methods of contraception.
  4. Acceptable results (within two times the normal limit) on laboratory screening tests (e.g., thyroid function).

Exclusion Criteria:

  1. Active suicidality.
  2. History of non-response to antidepressant treatment, or any previous treatment with lamotrigine.
  3. History of substance dependence in the past year, or abuse within the 4 weeks prior to study entry.
  4. Rapid cycling bipolar disorder.
  5. Receiving additional psychoactive medication (not including lorazepam for agitation), or has started a new course of psychotherapy within the last month.
  6. Received treatment for an anxiety or eating disorder within the last 12 months.
  7. Investigational drug use within the last month.
  8. History of epilepsy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989727


Locations
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Canada, Saskatchewan
Department of Psychiatry, Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N0W8
Sponsors and Collaborators
University of Saskatchewan
GlaxoSmithKline
Investigators
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Study Director: Rudy C Bowen, FRCPC University of Saskatchewan

Additional Information:
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Responsible Party: Evyn Peters, Resident, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02989727     History of Changes
Other Study ID Numbers: GSK-SCA100223
First Posted: December 12, 2016    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for the study (GSK-SCA100223; NCT00274677) is available through www.clinicalstudydatarequest.com.
Additional relevant MeSH terms:
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Lamotrigine
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers