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Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

Primary Purpose

Depression, Bipolar Disorder, Bipolar Depression

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Minocycline
Celecoxib
Placebo
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-65 years;
  • Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder and current major depressive disorder;
  • Experiencing current depressive symptoms for at least 4 weeks (HAMD-17 score ≥18);
  • Competent and willing to give informed consent;
  • Taking the current medication for a minimum of 4 week prior to baseline;
  • Able to take oral medication;
  • If female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.

Exclusion Criteria:

  • Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis);
  • Prior history of intolerance to any of the tetracyclines or NSAIDs;
  • Concomitant penicillin therapy;
  • Concomitant anticoagulant therapy;
  • Presence of a seizure disorder;
  • Currently taking other antibiotics, other NSAIDs, acetazolamide, or methotrexate;
  • Any change of psychotropic medications within the previous 4 weeks;
  • Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-5 criteria;
  • Pregnant or breast-feeding;
  • Presence of primary psychotic disorder;
  • Serious risk of suicide;
  • Current three or more manic/hypomanic symptoms.

Sites / Locations

  • Dow University of Health Sciences
  • Institute of Behavioural Sciences
  • Karwan-e-Hayat
  • Abbasi Shaheed Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Minocycline with TAU

Celecoxib with TAU

Minocycline and celecoxib with TAU

Placebo with TAU

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Scale scores

Secondary Outcome Measures

Full Information

First Posted
March 4, 2016
Last Updated
August 2, 2019
Sponsor
Pakistan Institute of Living and Learning
Collaborators
Dow University of Health Sciences, Abbasi Shaheed Hospital, Rawalpindi Medical College, Pakistan, University of Manchester, Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02703363
Brief Title
Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression
Official Title
Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression: A Factorial Design Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
Dow University of Health Sciences, Abbasi Shaheed Hospital, Rawalpindi Medical College, Pakistan, University of Manchester, Stanley Medical Research Institute

4. Oversight

5. Study Description

Brief Summary
Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients with bipolar disorder experience persistent depressive symptoms that do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, has also shown promising results in the treatment of depressive symptoms. In this factorial design, double blind, randomised controlled trial the investigators will determine the efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in patients experiencing a depressive phase of bipolar I or II disorder. The investigators hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement in depressive symptoms in participants in comparison with placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar Disorder, Bipolar Depression, Mood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline with TAU
Arm Type
Experimental
Arm Title
Celecoxib with TAU
Arm Type
Experimental
Arm Title
Minocycline and celecoxib with TAU
Arm Type
Experimental
Arm Title
Placebo with TAU
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Hamilton Depression Scale scores
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-65 years; Diagnostic and Statistical Manual-5 (DSM 5) diagnosis of bipolar I or II disorder and current major depressive disorder; Experiencing current depressive symptoms for at least 4 weeks (HAMD-17 score ≥18); Competent and willing to give informed consent; Taking the current medication for a minimum of 4 week prior to baseline; Able to take oral medication; If female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests. Exclusion Criteria: Relevant medical illness (HIV, renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis); Prior history of intolerance to any of the tetracyclines or NSAIDs; Concomitant penicillin therapy; Concomitant anticoagulant therapy; Presence of a seizure disorder; Currently taking other antibiotics, other NSAIDs, acetazolamide, or methotrexate; Any change of psychotropic medications within the previous 4 weeks; Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-5 criteria; Pregnant or breast-feeding; Presence of primary psychotic disorder; Serious risk of suicide; Current three or more manic/hypomanic symptoms.
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
69000
Country
Pakistan
Facility Name
Institute of Behavioural Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
72000
Country
Pakistan
Facility Name
Karwan-e-Hayat
City
Karachi
State/Province
Sindh
ZIP/Postal Code
72000
Country
Pakistan
Facility Name
Abbasi Shaheed Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32445690
Citation
Husain MI, Chaudhry IB, Khoso AB, Husain MO, Hodsoll J, Ansari MA, Naqvi HA, Minhas FA, Carvalho AF, Meyer JH, Deakin B, Mulsant BH, Husain N, Young AH. Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial. Lancet Psychiatry. 2020 Jun;7(6):515-527. doi: 10.1016/S2215-0366(20)30138-3. Epub 2020 May 20.
Results Reference
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Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression

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