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Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 12 - Visit 11 or Early Withdrawal

- 20-09-21 - 1 Formulier, 8 Itemgroepen, 58 Data-elementen, 1 Taal
Itemgroepen: Early Withdrawal, Vital Signs, Physical Examination, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Quality of Life Assessment, Investigational Product Dosing
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 12 - Visit 11 or Early Withdrawal.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 8 - Visit 9

- 19-04-18 - 1 Formulier, 5 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Investigational Product Dosing
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 8 - Visit 9.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 10 - Visit 10

- 19-04-18 - 1 Formulier, 5 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Investigational Product Dosing
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 10 - Visit 10.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 15 - Visit 13: 7-Day Follow-up

- 19-04-18 - 1 Formulier, 4 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Pregnancy Test, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 15 - Visit 13: 7-Day Follow-up.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Week 4 - Visit 6

- 19-04-18 - 1 Formulier, 5 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Investigational Product dosing
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Week 4 - Visit 6.

Evaluation of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive to Atypical Antipsychotic Agents in Schizophrenia NCT00086593 - Baseline Visit

- 19-04-18 - 1 Formulier, 5 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Psychiatric Evaluation, Pharmacokinetic Sampling, Atypical Antipsychotic Dosing, Quality of Life Assessment
Study ID: 101464 Clinical Study ID: SCA101464 Study Title: A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00086593 https://clinicaltrials.gov/ct2/show/NCT00086593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Study Indication: Lamictal XR,Lamictal,LAMICTIN This ODM form contains Baseline Visit.

Eligibility Schizophrenia NCT00159120

- 10-02-16 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00159120

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