DepressionPhase 3NCT00652171
Efficacy and Safety of Antidepressant Augmentation With Lamotrigine
A Phase 3 study testing Lamotrigine and Amide in people with Depression, run by Institute of Social Security of the Civil Servants of Minas Gerais.
Trial summary
This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Lamotrigine and Amide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- They were selected according to a clinical interview based on DSM-IV criteria for major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides
- They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush11
- failure to respond to treatment with at least 2 antidepressants of different classes
- at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms
Who cannot join
- Pregnant or lactating women or those capable of getting pregnant that who were not using contraceptive methods were excluded as well as patients with severe clinical diseases or organic mental disorder
- Further exclusion criteria were acute depression with risk of suicide
- psychosis
- and bipolar disorder as well as personality disorders and disorders related to alcohol and other drugs
About this study
Official title: Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression
This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.
Read the detailed description
Objective: This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.
Method: A double-blind pilot study was conducted with 34 nonbipolar, nonpsychotic patients who had DSM-IV major depressive disorder and were resistant to at least 2 antidepressants. The subjects were on taking antidepressant therapy and were randomly assigned to receive placebo or lamotrigine as an adjunct therapy for 8 weeks. They were evaluated on a biweekly basis in order to access assess the efficacy and the safety of the drug.
- Conditions
- Depression
- Being tested
- Lamotrigine, Amide
- Keywords
- Treatment, Augmentation, Resistant depression, Lamotrigine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Lamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day.
AmideDietary supplement
Capsule of amide were given to this group of patients. They continued the ongoing antidepressants.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 17 Patients - Mean age of 26 years old, 14 female and 3 male - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms. Receives: Drug: Lamotrigine |
| 2 | Placebo comparator | 17 Patients - 11 females and 6 males mean age of 29 years old - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms. Receives: Dietary Supplement: Amide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery and Asberg Scale for Depression
Measured: 8 weeks
Secondary outcomes (1)
Clinical Global Impression
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJan 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Social Security of the Civil Servants of Minas Gerais
- Sponsor type
- Other government
- Investigators
- Milena A Santos, Master, Principal investigator, City Hall of Beló HorizonteClaudia Hara, Master, Study chair, Faculdade de Saúde e Ecologia HumanaFabio L Rocha, PhD, Study director, Institute of Social Security of the Civil Servants of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652171
- Sponsor's protocol ID
- CEP: 093/03
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barbosa L, Berk M, Vorster M. A double-blind, randomized, placebo-controlled trial of augmentation with lamotrigine or placebo in patients concomitantly treated with fluoxetine for resistant major depressive episodes. J Clin Psychiatry. 2003 Apr;64(4):403-7. doi: 10.4088/jcp.v64n0407.
PubMed 12716240Rocha FL, Hara C. Lamotrigine augmentation in unipolar depression. Int Clin Psychopharmacol. 2003 Mar;18(2):97-9. doi: 10.1097/00004850-200303000-00006.
PubMed 12598821Barbee JG, Jamhour NJ. Lamotrigine as an augmentation agent in treatment-resistant depression. J Clin Psychiatry. 2002 Aug;63(8):737-41. doi: 10.4088/jcp.v63n0813.
PubMed 12197456Santos MA, Rocha FL, Hara C. Efficacy and safety of antidepressant augmentation with lamotrigine in patients with treatment-resistant depression: a randomized, placebo-controlled, double-blind study. Prim Care Companion J Clin Psychiatry. 2008;10(3):187-90. doi: 10.4088/pcc.v10n0302.
PubMed 18615166
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Antidepressant Augmentation With Lamotrigine in Patients With Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT00652171
- Acronym / sponsor ID
- CEP: 093/03
- Conditions
- Depression
- Keywords
- Treatment, Augmentation, Resistant depression, Lamotrigine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Institute of Social Security of the Civil Servants of Minas GeraisOther government
- Study start
- Jan 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.
Detailed description
Objective: This study reports a clinical trial evaluating lamotrigine safety and efficacy as an antidepressant augmentation agent in treatment resistant depression, therefore adding more empirical evidence to the limited number of studies on the use of lamotrigine.
Method: A double-blind pilot study was conducted with 34 nonbipolar, nonpsychotic patients who had DSM-IV major depressive disorder and were resistant to at least 2 antidepressants. The subjects were on taking antidepressant therapy and were randomly assigned to receive placebo or lamotrigine as an adjunct therapy for 8 weeks. They were evaluated on a biweekly basis in order to access assess the efficacy and the safety of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lamotrigine17 Patients - Mean age of 26 years old, 14 female and 3 male - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms. |
| 2 | Placebo comparator | Dietary Supplement: Amide17 Patients - 11 females and 6 males mean age of 29 years old - with major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides, They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush: failure to respond to treatment with at least 2 antidepressants of different classes, at the maximum tolerated dose for at least 6 weeks and absence of psychotic symptoms. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- They were selected according to a clinical interview based on DSM-IV criteria for major depressive disorder in single or recurrent episodes, with moderate to severe intensity. Besides
- They also had a history of treatment-resistant depression stage II or above according to the criteria of by Thase and Rush11
Key exclusion criteria (4 listed)
- Pregnant or lactating women or those capable of getting pregnant that who were not using contraceptive methods were excluded as well as patients with severe clinical diseases or organic mental disorder
- Further exclusion criteria were acute depression with risk of suicide
- psychosis
- and bipolar disorder as well as personality disorders and disorders related to alcohol and other drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LamotrigineLamotrigine was added to the ongoing antidepressant. The doses were titrated to 200mg/day. | Drug | 1 |
| AmideCapsule of amide were given to this group of patients. They continued the ongoing antidepressants. | Dietary supplement | 2 |
Primary outcome
Montgomery and Asberg Scale for Depression
Time frame: 8 weeks
1 secondary outcome
Clinical Global Impression
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2008.
- Background: PubMed 12716240Barbosa L, Berk M, Vorster M. A double-blind, randomized, placebo-controlled trial of augmentation with lamotrigine or placebo in patients concomitantly treated with fluoxetine for resistant major depressive episodes. J Clin Psychiatry. 2003 Apr;64(4):403-7. doi: 10.4088/jcp.v64n0407.
- Background: PubMed 12598821Rocha FL, Hara C. Lamotrigine augmentation in unipolar depression. Int Clin Psychopharmacol. 2003 Mar;18(2):97-9. doi: 10.1097/00004850-200303000-00006.
- Background: PubMed 12197456Barbee JG, Jamhour NJ. Lamotrigine as an augmentation agent in treatment-resistant depression. J Clin Psychiatry. 2002 Aug;63(8):737-41. doi: 10.4088/jcp.v63n0813.
- Derived from this study: PubMed 18615166Santos MA, Rocha FL, Hara C. Efficacy and safety of antidepressant augmentation with lamotrigine in patients with treatment-resistant depression: a randomized, placebo-controlled, double-blind study. Prim Care Companion J Clin Psychiatry. 2008;10(3):187-90. doi: 10.4088/pcc.v10n0302.
- FDA, Overview of LamotrigineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milena A Santos, Master principal investigator
City Hall of Beló Horizonte
Claudia Hara, Master study chair
Faculdade de Saúde e Ecologia Humana
Fabio L Rocha, PhD study director
Institute of Social Security of the Civil Servants of Minas Gerais
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamotrigine and Amide in people with Depression, run by Institute of Social Security of the Civil Servants of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery and Asberg Scale for Depression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00652171, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2008.